Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications, 33310-33314 [2011-14164]
Download as PDF
<![CDATA[
33310
Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices
and verification requirements of section
505(q) and has also made revisions to
clarify aspects of the guidance.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on citizen petitions and
petitions for stay of action that are
subject to section 505(q) of the FD&C
Act. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act (44 U.S.C. 3501–3520).
The collections of information in this
guidance were approved under OMB
control number 0910–0679. This
guidance also refers to previously
approved collections of information
found in FDA regulations and approved
under OMB control number 0910–0183
(21 CFR 10.20, 10.30, and 10.35) and
OMB control number 0910–0001 (21
CFR 314.54, 314.94, and 314.102).
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–14058 Filed 6–7–11; 8:45 am]
BILLING CODE 4160–01–P
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 70 new drug applications
(NDAs) and 97 abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
DATES:
Effective Date: July 8, 2011.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
holders of the applications listed in
table 1 of this document have informed
FDA that these drug products are no
longer marketed and have requested that
FDA withdraw approval of the
applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0411]
Bristol-Myers Squibb Co. et al.;
Withdrawal of Approval of 70 New
Drug Applications and 97 Abbreviated
New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
TABLE 1
Drug
Applicant
NDA 007289 ........................
Trigesic and Trigesic with Codeine Tablets ....................
NDA 008248 ........................
Wyamine (mephentermine sulfate) Sulfate Injection ......
NDA 008834 ........................
Tronothane HCl (pramoxine hydrochloride (HCl)) ..........
NDA 009182 ........................
Gantrisin (sulfisoxazole acetyl) .......................................
NDA 011835 ........................
Hydrodiuril (hydrochlorothiazide (HCTZ)) Tablets ..........
NDA 011971 ........................
NDA 012302 ........................
Oretic (HCTZ) Tablets, 25 milligrams (mg) and 50 mg ..
Choloxin (dextrothyroxine sodium) Tablets, 1 mg, 2 mg,
4 mg, and 6 mg.
Aldoril (methyldopa/HCTZ) Tablets .................................
Serax (oxazepam) Capsules and Tablets ......................
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543–4000.
Baxter Healthcare Corp., 2 Esterbrook Lane, Cherry
Hill, NJ 08003–4099.
Abbott Laboratories, Dept. PA76/Bldg. AP30–1E, 200
Abbott Park Rd., Abbott Park, IL 60064–6157.
Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ
07110–1199.
Merck & Co., Inc., P.O. Box 1000, UG2C–50, North
Wales, PA 19454.
Abbott Laboratories.
Do.
NDA 013402 ........................
NDA 015539 ........................
NDA 016118 ........................
NDA 016402 ........................
sroberts on DSK5SPTVN1PROD with NOTICES
Application No.
Teslac (testolactone) Tablets ..........................................
Alupent (metaproterenol sulfate) Inhalation Aerosol 1 ....
NDA 016666 ........................
Hippuran (hippuran I–131) Injection ...............................
NDA 016979 ........................
NDA 017015 ........................
Megace (megestrol acetate) Tablets, 20 mg and 40 mg
Pavulon (pancuronium bromide) Injection ......................
NDA 017352 ........................
Fastin (phentermine HCl) Capsules ................................
VerDate Mar<15>2010
21:51 Jun 07, 2011
Jkt 223001
PO 00000
Frm 00120
Fmt 4703
Sfmt 4703
Merck & Co., Inc.
Alpharma U.S. Pharmaceuticals Division, c/o King
Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN
37620.
Bristol-Myers Squibb Co.
Boehringer Ingelheim, 900 Ridgebury Rd., P.O. Box
368, Ridgefield, CT 06877–0368.
Mallinckrodt Medical Inc., c/o Covidien, 675 McDonnell
Blvd., Hazelwood, MO 63042.
Bristol-Myers Squibb Co.
Organon USA Inc., c/o Schering-Plough Corp., 2000
Galloping Hill Rd., Kenilworth, NJ 07033–0530.
GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709–3398.
E:\FR\FM\08JNN1.SGM
08JNN1
Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices
33311
TABLE 1—Continued
Application No.
Drug
Applicant
NDA 017628 ........................
Tolectin (tolmetin sodium) Tablets, 200 mg and 600 mg
NDA 017920 ........................
Tagamet (cimetidine) Tablets, 100 mg, 200 mg, 300
mg, 400 mg, and 800 mg.
Tagamet (cimetidine) Oral Solution, 300 mg/5 milliliters
(mL).
Lente Iletin (insulin zinc suspension purified beef-pork)
Ortho-McNeil Pharmaceutical, Inc., c/o Johnson &
Johnson Pharmaceutical Research & Development,
LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ
08560–0200.
GlaxoSmithKline.
NDA 017924 ........................
NDA 017933 ........................
NDA 017934 ........................
NDA 017939 ........................
NDA 018084 ........................
Similente Iletin (insulin zinc suspension purified beefpork).
Tagamet (cimetidine) Injection, 150 mg/mL ...................
Tolectin DS (tolmetin sodium) Capsules ........................
NDA
NDA
NDA
NDA
NDA
NDA
NDA
........................
........................
........................
........................
........................
........................
........................
Dextrose and Sodium Chloride Injection USP ................
Lanoxicaps (digoxin) Capsules .......................................
Moduretic (amiloride HCl/HCTZ) Tablets ........................
Sodium Chloride Irrigation USP ......................................
Aminocaproic Acid Injection USP, 250 mg/mL ...............
Norcuron (vecuronium bromide) Injection .......................
Nimotop (nimodipine) Capsules ......................................
NDA 019008 ........................
Bretylium Tosylate in Dextrose Injection USP ................
NDA 019030 ........................
NDA 019058 ........................
Bretylium Tosylate Injection USP, 50 mg/mL .................
Tenormin (atenolol) Injection, 5 mg/10 mL .....................
NDA 019091 ........................
Ismo (isosorbide mononitrate) Tablets, 20 mg ...............
NDA
NDA
NDA
NDA
NDA 019546 ........................
Protamine Zinc (insulin zinc suspension beef) ...............
Lente Insulin (insulin zinc suspension beef) ...................
Cartrol (carteolol HCl) Tablets ........................................
Humulin L (insulin zinc suspension recombinant
human) Injection.
Tagamet (cimetidine HCl) in Sodium Chloride Injection,
Equivalent to (EQ) 6 mg Base/mL.
Dynacirc (isradipine) Capsules .......................................
NDA 019561 ........................
Micro-K LS (potassium chloride) .....................................
NDA 019571 ........................
NDA 019583 ........................
Humulin U (insulin zinc suspension extended recombinant human) Injection.
Relafen (nabumetone) Tablets .......................................
NDA 019591 ........................
NDA 019638 ........................
NDA 019735 ........................
Lariam (mefloquine HCl) Tablets, 250 mg ......................
Arduan (pipecuronium bromide) Injection .......................
Floxin (ofloxacin) Tablets ................................................
NDA 019979 ........................
Ticlid (ticlopidine HCl) Tablets ........................................
NDA 020027 ........................
Cardizen (diltiazem HCl) Injection ..................................
NDA 020100 ........................
Humulin 50/50 (insulin recombinant human and insulin
suspension isophane recombinant human).
Dobutamine HCl in 5% Dextrose Injection .....................
Teczem (enalapril maleate/diltiazem maleate) Extended-Release Tablets.
Flovent (fluticasone propionate) Inhalation Aerosol 1 .....
Flovent (fluticasone propionate) Inhalation Powder .......
Lexxel (enalapril maleate and felodipine) Extended-Release Tablets.
Cardizem (diltiazem HCl) Injection .................................
Etopophos (estoposide phosphate) Injection ..................
Diltiazem HCl Extended-Release Capsules, 120 mg,
180 mg, 240 mg, 300 mg, 360 mg, and 420 mg.
018096
018118
018201
018380
018590
018776
018869
019165
019168
019204
019377
........................
........................
........................
........................
NDA 019434 ........................
sroberts on DSK5SPTVN1PROD with NOTICES
NDA 020269 ........................
NDA 020507 ........................
NDA 020548 ........................
NDA 020549 ........................
NDA 020668 ........................
NDA 020792 ........................
NDA 020906 ........................
NDA 020939 ........................
VerDate Mar<15>2010
21:51 Jun 07, 2011
Jkt 223001
PO 00000
Frm 00121
Fmt 4703
Sfmt 4703
Do.
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN
46285.
Do.
GlaxoSmithKline.
Ortho-McNeil Pharmaceutical, Inc., c/o Johnson &
Johnson Pharmaceutical Research & Development,
LLC.
Hospira, Inc.
GlaxoSmithKline.
Merck & Co., Inc.
Do.
Baxter Healthcare Corp.
Organon USA Inc., c/o Schering-Plough Corp.
Bayer Healthcare Pharmaceuticals, Inc., P.O. Box
1000, Montville, NJ 07045.
Hospira, Inc., 275 North Field Dr., Bldg. H2, Lake Forest, IL 60045–5046.
Hospira, Inc.
AstraZeneca Pharmaceuticals LP, 1800 Concord Pike,
P.O. Box 8355, Wilmington, DE 19803–89355.
Promius Pharma, LLC, 200 Somerset Corporate Blvd.,
7th Floor, Bridgewater, NJ 08807.
Eli Lilly and Co.
Do.
Abbot Laboratories.
Do.
GlaxoSmithKline.
SmithKline Beecham Corp., d/b/a GlaxoSmithKline,
One Franklin Plaza, 200 North 16th St., Philadelphia,
PA 19102.
KV Pharmaceutical Co., One Corporate Woods Dr.,
Bridgeton, MO 63044.
Eli Lilly and Co.
SmithKline Beecham Corp., c/o GlaxoSmithKline, 2301
Renaissance Blvd., RN210, P.O. Box 61540, King of
Prussia, PA 19406.
Hoffmann-La Roche Inc.
Organon USA Inc., c/o Schering-Plough Corp.
Ortho-McNeil-Janssen Pharmaceuticals, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC, P.O. Box 300, 920 Route 202 South,
Raritan, NJ 08869–0602.
Roche Palo Alto LLC, c/o Hoffmann-La Roche Inc., 340
Kingsland St., Nutley, NJ 07110–1199.
Biovail Technologies Ltd., On Behalf of Biovail Laboratories International SRL, 700 Route 202/206 North,
Bridgewater, NJ 08807.
Eli Lilly and Co.
Hospira, Inc.
Biovail Technologies, Ltd.
GlaxoSmithKline.
Do.
AstraZeneca Pharmaceuticals LP.
Biovail Technologies, Ltd.
Bristol-Myers Squibb Co.
Biovail Technologies, Ltd.
E:\FR\FM\08JNN1.SGM
08JNN1
33312
Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices
TABLE 1—Continued
Application No.
Drug
Applicant
NDA 020961 ........................
Vitravene (fomivirsen sodium) Injection ..........................
NDA 020966 ........................
Sporanox (itraconazole) Injection ...................................
NDA 021084 ........................
NDA 021088 ........................
Skin Exposure Reduction Paste Against Chemical Warfare Agent (SERPACWA) (polyetrafluoroethylene and
perfluoropolymethylisopropyl ether).
Viadur (leuprolide acetate) Implant .................................
NDA 021281 ........................
Prevacid (lansoprazole) ..................................................
NDA 021435 ........................
Amvaz (amlodipine maleate) Tablets, 2.5 mg, 5 mg,
and 10 mg.
NDA 021486 ........................
Lidopel (lidocaine HCl and epinephrine) Solution ..........
NDA 021507 ........................
Prevacid NapraPac 250, Prevacid NapraPac 375, and
Prevacid NapraPac 500 (lansoprazole and naproxen)
Tablets.
Prevacid I.V. (lansoprazole) Injection .............................
Foradil Certihaler (formoterol fumarate) Inhalation Powder.
Zegerid (omeprazole/sodium bicarbonate/magnesium
hydroxide).
Lidocaine HCl Injection USP, 1% ...................................
Naphazoline HCl Ophthalmic Solution USP, 0.1% .........
Novartis Pharmaceuticals Corp., One Health Plaza,
East Hanover, NJ 07936–1080.
Ortho-McNeil-Janssen Pharmaceuticals, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC.
U.S. Army Medical Material Development Activity, c/o
Office of Surgeon General, 1430 Veterans Dr., Fort
Detrick, MD 21702–9234.
Ortho-McNeil-Janssen Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC.
Takeda Global Research and Development Center,
Inc., One Takeda Parkway, Deerfield, IL 60015.
Dr. Reddy’s Laboratories, Inc., 200 Somerset Corporate
Blvd., Bldg. II, 7th Floor, Bridgewater, NJ 08807–
2862.
Empi, Inc., P.O. Box 709, Highway 22 East, Clear
Lake, SD 57226.
Takeda Global Research and Development Center, Inc.
NDA 021566 ........................
NDA 021592 ........................
NDA 021850 ........................
ANDA 040013 ......................
ANDA 040073 ......................
ANDA 040095 ......................
ANDA 040224 ......................
ANDA 040360 ......................
ANDA 040522 ......................
Heparin Sodium Injection USP, 10,000 Units/mL ...........
Chlorpromazine HCl Oral Concentrate USP, 100 mg/
mL.
Perphenazine Oral Solution USP, 16 mg/5 mL ..............
Norepinephrine Bitartrate Injection USP, EQ 1 mg
(base)/1 mL.
NDA 050521 ........................
NDA 050522 ........................
NDA 050560 ........................
Ceclor (cefaclor) Capsules, 250 mg and 500 mg ...........
Ceclor (cefaclor) Suspension ..........................................
Cefizox (ceftizoxime sodium) Powder for Injection .........
ANDA 061394 ......................
Principen (ampicillin for oral suspension USP) ..............
ANDA 061886 ......................
Trimox (amoxicillin for oral suspension USP), 50 mg/
mL, 125 mg/5 mL, and 250 mg/5 mL.
Mutamycin (mitomycin for injection USP) 5 mg, 20 mg,
and 40 mg Vials.
Kefzol (cefazolin sodium for injection USP) ...................
Erythromycin Lactobionate for Injection USP .................
ANDA 062336 ......................
ANDA 062557 ......................
ANDA 062563 ......................
ANDA 062885 ......................
ANDA 070225 ......................
Trimox (amoxicillin for oral suspension USP), 125 mg/5
mL and 250 mg/5 mL.
Erythromycin Lactobionate for Injection USP, EQ 500
mg (base) and 1 gram (g) (base) Vials.
Cefizox (ceftizoxime for injection USP), EQ 1 g (base)
and 2 g (base) Vials.
Verapamil HCl Injection USP, 2.5 mg/mL ......................
ANDA 070231 ......................
Carbamazepine Tablets USP, 200 mg ...........................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
Methyldopate HCl Injection USP, 50 mg/mL ..................
Verapamil HCl Injection USP, 2.5 mg/mL ......................
Bretylium Tosylate Injection USP, 50 mg/mL .................
Pancuronium Bromide Injection, 1 mg/mL ......................
Pancuronium Bromide Injection, 2 mg/mL ......................
Pancuronium Bromide Injection, 2 mg/mL ......................
Droperidol Injection USP, 2.5 mg/mL .............................
Droperidol Injection USP, 2.5 mg/mL .............................
Dipivefrin HCl Ophthalmic Solution USP, 0.1% ..............
Etoposide Injection, 20 mg/mL .......................................
Etoposide Injection, 20 mg/mL .......................................
Cimetidine HCl Injection USP .........................................
ANDA 062993 ......................
sroberts on DSK5SPTVN1PROD with NOTICES
ANDA 063294 ......................
070291
070617
070891
072058
072059
072060
072272
072335
074188
074320
074351
074353
VerDate Mar<15>2010
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
21:51 Jun 07, 2011
Jkt 223001
PO 00000
Frm 00122
Fmt 4703
Sfmt 4703
Do.
Novartis Pharmaceuticals Corp.
Santarus, Inc., 3721 Valley Center Dr., suite 400, San
Diego, CA 92130.
Hospira, Inc.
Bausch & Lomb, Inc., 7 Giralda Farms, suite 1001,
Madison, NJ 07940.
Hospira, Inc.
Pharmaceutical Associates, Inc., 201 Delaware St.,
Greenville, SC 29605.
Do.
Metrics
Pharmaceuticals
Ventures,
LLC,
c/o
Pharmaforce Inc., 960 Crupper Ave., Columbus, OH
43229.
Eli Lilly and Co.
Do.
Astellas Pharma US, Inc., 3 Parkway North, Deerfield,
IL 60015.
Apothecon, Inc., c/o Bristol-Myers Squibb Co., P.O.
Box 4000, Princeton, NJ 08543–4000.
Do.
Bristol-Myers Squibb Co.
Eli Lilly and Co.
Elkins-Sinn, Inc., c/o Baxter Healthcare Corp., 2
Esterbrook Lane, Cherry Hill, NJ 08003–4002.
Apothecon, Inc., c/o Bristol-Myers Squibb Co.
Baxter Healthcare Corp.
Astellas Pharma US, Inc., Three Parkway North, Deerfield, IL 60015–2548.
Luitpold Pharmaceuticals, Inc., One Luitpold Dr., P.O.
Box 9001, Shirley, NY 11967.
Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc., Harborside Financial Center, Plaza
Three, suite 602, Jersey City, NJ 07311.
Baxter Healthcare Corp.
Luitpold Pharmaceuticals, Inc.
Do.
Elkins-Sinn, Inc., c/o Baxter Healthcare Corp.
Do.
Do.
Hospira, Inc.
Luitpold Pharmaceuticals, Inc.
Bausch & Lomb, Inc.
Hospira, Inc.
Do.
Luitpold Pharmaceuticals, Inc.
E:\FR\FM\08JNN1.SGM
08JNN1
Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices
33313
TABLE 1—Continued
Application No.
Drug
Applicant
......................
......................
......................
......................
......................
Dobutamine Injection USP, 12.5 mg (base)/mL .............
Dobutamine Injection USP, 12.5 mg/mL ........................
Dobutamine Injection USP, 12.5 mg/mL ........................
Minoxidil Topical Solution, 2% ........................................
Minoxidil Topical Solution, 2% ........................................
ANDA 074824 ......................
ANDA 074825 ......................
ANDA 075341 ......................
Atracurium Besylate Injection USP, 10 mg/mL ..............
Atracurium Besylate Injection USP, 10 mg/mL ..............
Ketoconazole Tablets USP, 200 mg ...............................
ANDA
ANDA
ANDA
ANDA
Enalaprilat Injection, 1.25 mg/mL ...................................
Amrinone (inamrinone injection USP) EQ 5 mg/mL .......
Fluconazole in Sodium Chloride 0.9% Injection .............
Fenoldopam Mesylate Injection USP, EQ 10 mg (base)/
mL.
Ondansetron Injection USP, EQ 2 mg (base)/mL ..........
Ondansetron Injection USP, EQ 2 mg (base)/mL ..........
Terbinafine HCl Tablets, EQ 250 mg (base) ..................
Baxter Healthcare Corp.
Luitpold Pharmaceuticals, Inc.
Hospira, Inc.
Bausch & Lomb, Inc.
Sight Pharmaceuticals, Inc., 7 Giralda Farms, suite
1001, Madison, NJ 07940.
Baxter Healthcare Corp.
Do.
AAIPharma Service Corp., 2320 Scientific Park Dr.,
Wilmington, NC 28405.
Hospira, Inc.
Baxter Healthcare Corp.
Hospira, Inc.
Luitpold Pharmaceuticals, Inc.
ANDA
ANDA
ANDA
ANDA
ANDA
074381
074545
074634
074643
074743
075456
075542
076617
076656
......................
......................
......................
......................
ANDA 076695 ......................
ANDA 076696 ......................
ANDA 077065 ......................
ANDA 077333 ......................
ANDA 077389 ......................
ANDA 077392 ......................
Amlodipine Besylate Tablets, EQ 2.5 mg (base), 5 mg
(base), and 10 mg (base).
Carboplatin Injection .......................................................
ANDA 077994 ......................
Lamotrigine Tablets, 25 mg, 100 mg, 150, mg, and 200
mg.
Ironotecan HCl Injection ..................................................
ANDA 080416 ......................
ANDA 083346 ......................
ANDA 084178 ......................
Procaine HCl Injection USP, 1% and 2% .......................
Isoproterenol HCl Injection USP, 0.2 mg/mL ..................
Methyltestosterone Tablets, 5 mg ...................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
084179
084312
084767
085284
085285
085289
085363
......................
......................
......................
......................
......................
......................
......................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
085384
085385
085388
085466
085492
085493
085551
......................
......................
......................
......................
......................
......................
......................
Methyltestosterone Tablets, 25 mg .................................
Methyltestosterone Tablets, 10 mg .................................
Dimenhydrinate Injection USP ........................................
Aminophylline Tablets, 100 mg .......................................
Secobarbital Sodium Capsules, 100 mg ........................
Aminophylline Tablets, 200 mg .......................................
Acetaminophen and Codeine Phosphate Tablets, 325
mg/45 mg.
Triprolidine HCl Syrup, 1.25mg/5 mL .............................
Promethazine HCl Syrup, 25 mg/5 mL ...........................
Promethazine HCl Syrup, 6.25 mg/5 mL ........................
Brompheniramine Maleate Elixir, 2 mg/5 mL .................
Acetic Acid with Hydrocortisone Otic Solution, 2%/1% ..
Acetic Acid Otic Solution, 2% .........................................
Hydroxyzine HCl Injection USP, 25 mg/mL and 50 mg/
mL.
Diphenhydramine HCl Elixir, 12.5 mg/5 mL ...................
Prednisone Tablets, 5 mg ...............................................
Hydrocortisone Sodium Succinate for Injection USP,
EQ 100 mg (base)/Vial.
Donnatal (phenobarbital, hyoscyamine sulfate, atropine
sulfate, scopolamine (HBr)) Elixir.
Donnatal (phenobarbital, hyoscyamine sulfate, atropine
sulfate, scopolamine (HBr)) Tablets.
Donnatal (phenobarbital, hyoscyamine sulfate, atropine
sulfate, scopolamine (HBr)) Capsules.
Novocain (procaine HCl injection USP) 10% .................
Methylprednisolone Sodium Succinate for Injection
USP, EQ 40 mg (base), 125 mg (base), 500 mg
(base), and 1 g (base) Vials.
Aminophylline Injection USP, 25 mg/mL ........................
Aminophylline Injection USP, 25 mg/mL ........................
Chlorthalidone Tablets, 25 mg ........................................
Chlorthalidone Tablets, 50 mg ........................................
Muro Opcon (naphazoline HCl ophthalmic solution
USP, 0.1%).
Hydrocortisone Sodium Succinate for Injection USP,
EQ 250 mg (base)/Vial.
Hydrocortisone Sodium Succinate for Injection USP,
EQ 500 mg (base)/Vial.
ANDA 085621 ......................
ANDA 085810 ......................
ANDA 086619 ......................
ANDA 086661 ......................
ANDA 086676 ......................
ANDA 086677 ......................
sroberts on DSK5SPTVN1PROD with NOTICES
ANDA 086797 ......................
ANDA 086906 ......................
ANDA
ANDA
ANDA
ANDA
ANDA
087239
087240
087311
087312
087506
......................
......................
......................
......................
......................
ANDA 087567 ......................
ANDA 087568 ......................
VerDate Mar<15>2010
21:51 Jun 07, 2011
Jkt 223001
PO 00000
Frm 00123
Fmt 4703
Sfmt 4703
Hospira, Inc.
Do.
Gedeon Richter PLC, c/o Gedeon Richter USA, Inc.,
1200 East Ridgewood Ave., Ridgewood, NJ 07450.
Do.
Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA
92618.
Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus,
OH 43228.
Sandoz, Inc., 2555 West Midway Blvd., Broomfield, CO
80038–0446.
Hospira, Inc.
Do.
KV Pharmaceutical Co., One Corporate Woods Dr.,
Bridgeton, MO 63044.
Do.
Do.
Baxter Healthcare Corp.
KV Pharmaceutical Co.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Baxter Healthcare Corp.
KV Pharmaceutical Co.
Do.
Baxter Healthcare Corp.
A.H. Robins Co., c/o Wyeth Pharmaceuticals, Inc., P.O.
Box 8299, Philadelphia, PA 19101–8299.
Do.
Do.
Hospira, Inc.
Elkins-Sinn, Inc., c/o Baxter Healthcare Corp.
Do.
Luitpold Pharmaceuticals, Inc.
KV Pharmaceutical Co.
Do.
Bausch & Lomb, Inc.
Baxter Healthcare Corp.
Do.
E:\FR\FM\08JNN1.SGM
08JNN1
33314
Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Notices
TABLE 1—Continued
Application No.
Drug
ANDA 087569 ......................
Hydrocortisone Sodium Succinate for Injection USP,
EQ 1 g (base)/Vial.
Potassium Chloride for Injection Concentrate USP ........
Aminophylline Injection USP, 25 mg/mL ........................
Vitamin K1 (phytonadione injection emulsion USP), 10
mg/mL.
Meperidine HCl Injection USP, 25 mg/mL ......................
Meperidine HCl Injection USP, 50 mg/mL ......................
Meperidine HCl Injection USP, 75 mg/mL ......................
Meperidine HCl Injection USP, 100 mg/mL ....................
Lidocaine HCl Injection USP, 1.5% ................................
Lidocaine HCl Injection USP, 2% ...................................
Lidocaine HCl Injection USP, 20% .................................
Cyclophosphamide for Injection USP, 100 mg/Vial ........
Cyclophosphamide for Injection USP, 200 mg/Vial ........
Cyclophosphamide for Injection USP, 500 mg/Vial ........
Cyclophosphamide for Injection USP, 1 g/Vial ...............
Lidocaine HCl and Epinephrine Injection ........................
Prochlorperazine Edisylate Injection USP, EQ 5 mg
(base)/mL.
Perphenazine Tablets USP, 2 mg ..................................
ANDA 087584 ......................
ANDA 087601 ......................
ANDA 087956 ......................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
088279
088280
088281
088282
088326
088331
088368
088371
088372
088373
088374
089649
089703
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
ANDA 089707 ......................
ANDA 090954 ......................
Applicant
Cromolyn Sodium Oral Solution Concentrate, 100 mg/5
mL.
Do.
Luitpold Pharmaceuticals, Inc.
Hospira, Inc.
Do.
Baxter Healthcare Corp.
Do.
Do.
Do.
Hospira, Inc.
Do.
Do.
Baxter Healthcare Corp.
Do.
Do.
Do.
Hospira, Inc.
Do.
Ivax Pharmaceuticals Inc., 400 Chestnut Ridge Rd.,
Woodcliff Lake, NJ 07677.
Pack Pharmaceuticals, LLC, 1110 West Lake Cook
Rd., suite 152, Buffalo Grove, IL 60089.
1 This product was an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no longer
be used as a propellant for any metaproterenol sulfate or fluticasone propionate metered-dose inhalers (see 75 FR 19213–19241, April 14, 2010;
71 FR 70870–70873, December 7, 2006).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 31, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
sroberts on DSK5SPTVN1PROD with NOTICES
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs, approval of the applications
listed in table 1 of this document, and
all amendments and supplements
thereto, is hereby withdrawn, effective
July 8, 2011. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the FD&C Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in
table 1 of this document that are in
inventory on the date that this notice
becomes effective (see the DATES
section) may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Statutory Authority
[FR Doc. 2011–14164 Filed 6–7–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
21:51 Jun 07, 2011
Jkt 223001
Indian Health Service
Background
Epidemiology Program for American
Indian/Alaska Native Tribes and Urban
Indian Communities
Division of Epidemiology and Disease
Prevention; Epidemiology Program for
American Indian/Alaska Native Tribes
and Urban Indian Communities
Announcement Type: New.
Funding Opportunity Number: HHS–
2011–IHS–EPI–0001.
Catalog of Federal Domestic
Assistance Number: 93.231
DATES: Key Dates:
Application Deadline Date: July 15,
2011;
≤Review Date: August 16–17, 2011;
Anticipated Start Date: September 16,
2011.
I. Funding Opportunity Description
The Indian Health Service (IHS) is
accepting competitive cooperative
agreement applications to establish
Tribal Epidemiology Centers serving
American Indian/Alaska Native (AI/AN)
Tribes and urban Indian communities.
This program is managed by the IHS
Division of Epidemiology and Disease
Prevention (DEDP). This program is
authorized under the Snyder Act, 25
U.S.C. 13, and 25 U.S.C. 1621m of the
PO 00000
Frm 00124
Fmt 4703
Sfmt 4703
Indian Health Care Improvement Act.
To obtain details regarding eligibility,
please refer to Section III below.
The Tribal Epidemiology Center (TEC)
program was authorized by Congress in
1998 as a way to provide public health
support to multiple Tribes and urban
Indian communities in each of the IHS
Areas. The funding opportunity
announcement is open to eligible
Tribes, Tribal organizations, intertribal
consortia, and urban Indian
organizations, including currently
funded TECs.
TECs are uniquely positioned within
Tribes, Tribal and urban Indian
organizations to conduct disease
surveillance, research, prevention and
control of disease, injury, or disability,
and to assess the effectiveness of AI/AN
public health programs. In addition,
they can fill gaps in data needed for
Government Performance and Results
Act (GPRA) and Healthy People 2020
measures. Some of the existing TECs
have already developed innovative
strategies to monitor the health status of
Tribes and urban Indian communities,
including development of Tribal health
registries and use of sophisticated
record linkage computer software to
correct existing state data sets for racial
misclassification. TECs work in
partnership with IHS DEDP to provide
a more accurate national picture of
Indian health status.
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Notices]
[Pages 33310-33314]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14164]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0411]
Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New
Drug Applications and 97 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 70 new drug applications (NDAs) and 97 abbreviated new drug
applications (ANDAs) from multiple applicants. The holders of the
applications notified the Agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.
DATES: Effective Date: July 8, 2011.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 of this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
Table 1
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 007289.................. Trigesic and Bristol-Myers Squibb
Trigesic with Co., P.O. Box 4000,
Codeine Tablets. Princeton, NJ 08543-
4000.
NDA 008248.................. Wyamine Baxter Healthcare
(mephentermine Corp., 2 Esterbrook
sulfate) Sulfate Lane, Cherry Hill,
Injection. NJ 08003-4099.
NDA 008834.................. Tronothane HCl Abbott Laboratories,
(pramoxine Dept. PA76/Bldg.
hydrochloride AP30-1E, 200 Abbott
(HCl)). Park Rd., Abbott
Park, IL 60064-
6157.
NDA 009182.................. Gantrisin Hoffman-La Roche,
(sulfisoxazole Inc., 340 Kingsland
acetyl). St., Nutley, NJ
07110-1199.
NDA 011835.................. Hydrodiuril Merck & Co., Inc.,
(hydrochlorothiazid P.O. Box 1000, UG2C-
e (HCTZ)) Tablets. 50, North Wales, PA
19454.
NDA 011971.................. Oretic (HCTZ) Abbott Laboratories.
Tablets, 25
milligrams (mg) and
50 mg.
NDA 012302.................. Choloxin Do.
(dextrothyroxine
sodium) Tablets, 1
mg, 2 mg, 4 mg, and
6 mg.
NDA 013402.................. Aldoril (methyldopa/ Merck & Co., Inc.
HCTZ) Tablets.
NDA 015539.................. Serax (oxazepam) Alpharma U.S.
Capsules and Pharmaceuticals
Tablets. Division, c/o King
Pharmaceuticals,
Inc., 501 Fifth
St., Bristol, TN
37620.
NDA 016118.................. Teslac Bristol-Myers Squibb
(testolactone) Co.
Tablets.
NDA 016402.................. Alupent Boehringer
(metaproterenol Ingelheim, 900
sulfate) Inhalation Ridgebury Rd., P.O.
Aerosol \1\. Box 368,
Ridgefield, CT
06877-0368.
NDA 016666.................. Hippuran (hippuran I- Mallinckrodt Medical
131) Injection. Inc., c/o Covidien,
675 McDonnell
Blvd., Hazelwood,
MO 63042.
NDA 016979.................. Megace (megestrol Bristol-Myers Squibb
acetate) Tablets, Co.
20 mg and 40 mg.
NDA 017015.................. Pavulon (pancuronium Organon USA Inc., c/
bromide) Injection. o Schering-Plough
Corp., 2000
Galloping Hill Rd.,
Kenilworth, NJ
07033-0530.
NDA 017352.................. Fastin (phentermine GlaxoSmithKline,
HCl) Capsules. P.O. Box 13398,
Five Moore Dr.,
Research Triangle
Park, NC 27709-
3398.
[[Page 33311]]
NDA 017628.................. Tolectin (tolmetin Ortho-McNeil
sodium) Tablets, Pharmaceutical,
200 mg and 600 mg. Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC,
1125 Trenton-
Harbourton Rd.,
Titusville, NJ
08560-0200.
NDA 017920.................. Tagamet (cimetidine) GlaxoSmithKline.
Tablets, 100 mg,
200 mg, 300 mg, 400
mg, and 800 mg.
NDA 017924.................. Tagamet (cimetidine) Do.
Oral Solution, 300
mg/5 milliliters
(mL).
NDA 017933.................. Lente Iletin Eli Lilly and Co.,
(insulin zinc Lilly Corporate
suspension purified Center,
beef-pork). Indianapolis, IN
46285.
NDA 017934.................. Similente Iletin Do.
(insulin zinc
suspension purified
beef-pork).
NDA 017939.................. Tagamet (cimetidine) GlaxoSmithKline.
Injection, 150 mg/
mL.
NDA 018084.................. Tolectin DS Ortho-McNeil
(tolmetin sodium) Pharmaceutical,
Capsules. Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC.
NDA 018096.................. Dextrose and Sodium Hospira, Inc.
Chloride Injection
USP.
NDA 018118.................. Lanoxicaps (digoxin) GlaxoSmithKline.
Capsules.
NDA 018201.................. Moduretic (amiloride Merck & Co., Inc.
HCl/HCTZ) Tablets.
NDA 018380.................. Sodium Chloride Do.
Irrigation USP.
NDA 018590.................. Aminocaproic Acid Baxter Healthcare
Injection USP, 250 Corp.
mg/mL.
NDA 018776.................. Norcuron (vecuronium Organon USA Inc., c/
bromide) Injection. o Schering-Plough
Corp.
NDA 018869.................. Nimotop (nimodipine) Bayer Healthcare
Capsules. Pharmaceuticals,
Inc., P.O. Box
1000, Montville, NJ
07045.
NDA 019008.................. Bretylium Tosylate Hospira, Inc., 275
in Dextrose North Field Dr.,
Injection USP. Bldg. H2, Lake
Forest, IL 60045-
5046.
NDA 019030.................. Bretylium Tosylate Hospira, Inc.
Injection USP, 50
mg/mL.
NDA 019058.................. Tenormin (atenolol) AstraZeneca
Injection, 5 mg/10 Pharmaceuticals LP,
mL. 1800 Concord Pike,
P.O. Box 8355,
Wilmington, DE
19803-89355.
NDA 019091.................. Ismo (isosorbide Promius Pharma, LLC,
mononitrate) 200 Somerset
Tablets, 20 mg. Corporate Blvd.,
7th Floor,
Bridgewater, NJ
08807.
NDA 019165.................. Protamine Zinc Eli Lilly and Co.
(insulin zinc
suspension beef).
NDA 019168.................. Lente Insulin Do.
(insulin zinc
suspension beef).
NDA 019204.................. Cartrol (carteolol Abbot Laboratories.
HCl) Tablets.
NDA 019377.................. Humulin L (insulin Do.
zinc suspension
recombinant human)
Injection.
NDA 019434.................. Tagamet (cimetidine GlaxoSmithKline.
HCl) in Sodium
Chloride Injection,
Equivalent to (EQ)
6 mg Base/mL.
NDA 019546.................. Dynacirc SmithKline Beecham
(isradipine) Corp., d/b/a
Capsules. GlaxoSmithKline,
One Franklin Plaza,
200 North 16th St.,
Philadelphia, PA
19102.
NDA 019561.................. Micro-K LS KV Pharmaceutical
(potassium Co., One Corporate
chloride). Woods Dr.,
Bridgeton, MO
63044.
NDA 019571.................. Humulin U (insulin Eli Lilly and Co.
zinc suspension
extended
recombinant human)
Injection.
NDA 019583.................. Relafen (nabumetone) SmithKline Beecham
Tablets. Corp., c/o
GlaxoSmithKline,
2301 Renaissance
Blvd., RN210, P.O.
Box 61540, King of
Prussia, PA 19406.
NDA 019591.................. Lariam (mefloquine Hoffmann-La Roche
HCl) Tablets, 250 Inc.
mg.
NDA 019638.................. Arduan (pipecuronium Organon USA Inc., c/
bromide) Injection. o Schering-Plough
Corp.
NDA 019735.................. Floxin (ofloxacin) Ortho-McNeil-Janssen
Tablets. Pharmaceuticals,
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC,
P.O. Box 300, 920
Route 202 South,
Raritan, NJ 08869-
0602.
NDA 019979.................. Ticlid (ticlopidine Roche Palo Alto LLC,
HCl) Tablets. c/o Hoffmann-La
Roche Inc., 340
Kingsland St.,
Nutley, NJ 07110-
1199.
NDA 020027.................. Cardizen (diltiazem Biovail Technologies
HCl) Injection. Ltd., On Behalf of
Biovail
Laboratories
International SRL,
700 Route 202/206
North, Bridgewater,
NJ 08807.
NDA 020100.................. Humulin 50/50 Eli Lilly and Co.
(insulin
recombinant human
and insulin
suspension isophane
recombinant human).
NDA 020269.................. Dobutamine HCl in 5% Hospira, Inc.
Dextrose Injection.
NDA 020507.................. Teczem (enalapril Biovail
maleate/diltiazem Technologies, Ltd.
maleate) Extended-
Release Tablets.
NDA 020548.................. Flovent (fluticasone GlaxoSmithKline.
propionate)
Inhalation Aerosol
\1\.
NDA 020549.................. Flovent (fluticasone Do.
propionate)
Inhalation Powder.
NDA 020668.................. Lexxel (enalapril AstraZeneca
maleate and Pharmaceuticals LP.
felodipine)
Extended-Release
Tablets.
NDA 020792.................. Cardizem (diltiazem Biovail
HCl) Injection. Technologies, Ltd.
NDA 020906.................. Etopophos Bristol-Myers Squibb
(estoposide Co.
phosphate)
Injection.
NDA 020939.................. Diltiazem HCl Biovail
Extended-Release Technologies, Ltd.
Capsules, 120 mg,
180 mg, 240 mg, 300
mg, 360 mg, and 420
mg.
[[Page 33312]]
NDA 020961.................. Vitravene Novartis
(fomivirsen sodium) Pharmaceuticals
Injection. Corp., One Health
Plaza, East
Hanover, NJ 07936-
1080.
NDA 020966.................. Sporanox Ortho-McNeil-Janssen
(itraconazole) Pharmaceuticals,
Injection. Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC.
NDA 021084.................. Skin Exposure U.S. Army Medical
Reduction Paste Material
Against Chemical Development
Warfare Agent Activity, c/o
(SERPACWA) Office of Surgeon
(polyetrafluoroethy General, 1430
lene and Veterans Dr., Fort
perfluoropolymethyl Detrick, MD 21702-
isopropyl ether). 9234.
NDA 021088.................. Viadur (leuprolide Ortho-McNeil-Janssen
acetate) Implant. Pharmaceutical,
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC.
NDA 021281.................. Prevacid Takeda Global
(lansoprazole). Research and
Development Center,
Inc., One Takeda
Parkway, Deerfield,
IL 60015.
NDA 021435.................. Amvaz (amlodipine Dr. Reddy's
maleate) Tablets, Laboratories, Inc.,
2.5 mg, 5 mg, and 200 Somerset
10 mg. Corporate Blvd.,
Bldg. II, 7th
Floor, Bridgewater,
NJ 08807-2862.
NDA 021486.................. Lidopel (lidocaine Empi, Inc., P.O. Box
HCl and 709, Highway 22
epinephrine) East, Clear Lake,
Solution. SD 57226.
NDA 021507.................. Prevacid NapraPac Takeda Global
250, Prevacid Research and
NapraPac 375, and Development Center,
Prevacid NapraPac Inc.
500 (lansoprazole
and naproxen)
Tablets.
NDA 021566.................. Prevacid I.V. Do.
(lansoprazole)
Injection.
NDA 021592.................. Foradil Certihaler Novartis
(formoterol Pharmaceuticals
fumarate) Corp.
Inhalation Powder.
NDA 021850.................. Zegerid (omeprazole/ Santarus, Inc., 3721
sodium bicarbonate/ Valley Center Dr.,
magnesium suite 400, San
hydroxide). Diego, CA 92130.
ANDA 040013................. Lidocaine HCl Hospira, Inc.
Injection USP, 1%.
ANDA 040073................. Naphazoline HCl Bausch & Lomb, Inc.,
Ophthalmic Solution 7 Giralda Farms,
USP, 0.1%. suite 1001,
Madison, NJ 07940.
ANDA 040095................. Heparin Sodium Hospira, Inc.
Injection USP,
10,000 Units/mL.
ANDA 040224................. Chlorpromazine HCl Pharmaceutical
Oral Concentrate Associates, Inc.,
USP, 100 mg/mL. 201 Delaware St.,
Greenville, SC
29605.
ANDA 040360................. Perphenazine Oral Do.
Solution USP, 16 mg/
5 mL.
ANDA 040522................. Norepinephrine Metrics
Bitartrate Pharmaceuticals
Injection USP, EQ 1 Ventures, LLC, c/o
mg (base)/1 mL. Pharmaforce Inc.,
960 Crupper Ave.,
Columbus, OH 43229.
NDA 050521.................. Ceclor (cefaclor) Eli Lilly and Co.
Capsules, 250 mg
and 500 mg.
NDA 050522.................. Ceclor (cefaclor) Do.
Suspension.
NDA 050560.................. Cefizox (ceftizoxime Astellas Pharma US,
sodium) Powder for Inc., 3 Parkway
Injection. North, Deerfield,
IL 60015.
ANDA 061394................. Principen Apothecon, Inc., c/o
(ampicillin for Bristol-Myers
oral suspension Squibb Co., P.O.
USP). Box 4000,
Princeton, NJ 08543-
4000.
ANDA 061886................. Trimox (amoxicillin Do.
for oral suspension
USP), 50 mg/mL, 125
mg/5 mL, and 250 mg/
5 mL.
ANDA 062336................. Mutamycin (mitomycin Bristol-Myers Squibb
for injection USP) Co.
5 mg, 20 mg, and 40
mg Vials.
ANDA 062557................. Kefzol (cefazolin Eli Lilly and Co.
sodium for
injection USP).
ANDA 062563................. Erythromycin Elkins-Sinn, Inc., c/
Lactobionate for o Baxter Healthcare
Injection USP. Corp., 2 Esterbrook
Lane, Cherry Hill,
NJ 08003-4002.
ANDA 062885................. Trimox (amoxicillin Apothecon, Inc., c/o
for oral suspension Bristol-Myers
USP), 125 mg/5 mL Squibb Co.
and 250 mg/5 mL.
ANDA 062993................. Erythromycin Baxter Healthcare
Lactobionate for Corp.
Injection USP, EQ
500 mg (base) and 1
gram (g) (base)
Vials.
ANDA 063294................. Cefizox (ceftizoxime Astellas Pharma US,
for injection USP), Inc., Three Parkway
EQ 1 g (base) and 2 North, Deerfield,
g (base) Vials. IL 60015-2548.
ANDA 070225................. Verapamil HCl Luitpold
Injection USP, 2.5 Pharmaceuticals,
mg/mL. Inc., One Luitpold
Dr., P.O. Box 9001,
Shirley, NY 11967.
ANDA 070231................. Carbamazepine Inwood Laboratories,
Tablets USP, 200 mg. Inc., Subsidiary of
Forest
Laboratories, Inc.,
Harborside
Financial Center,
Plaza Three, suite
602, Jersey City,
NJ 07311.
ANDA 070291................. Methyldopate HCl Baxter Healthcare
Injection USP, 50 Corp.
mg/mL.
ANDA 070617................. Verapamil HCl Luitpold
Injection USP, 2.5 Pharmaceuticals,
mg/mL. Inc.
ANDA 070891................. Bretylium Tosylate Do.
Injection USP, 50
mg/mL.
ANDA 072058................. Pancuronium Bromide Elkins-Sinn, Inc., c/
Injection, 1 mg/mL. o Baxter Healthcare
Corp.
ANDA 072059................. Pancuronium Bromide Do.
Injection, 2 mg/mL.
ANDA 072060................. Pancuronium Bromide Do.
Injection, 2 mg/mL.
ANDA 072272................. Droperidol Injection Hospira, Inc.
USP, 2.5 mg/mL.
ANDA 072335................. Droperidol Injection Luitpold
USP, 2.5 mg/mL. Pharmaceuticals,
Inc.
ANDA 074188................. Dipivefrin HCl Bausch & Lomb, Inc.
Ophthalmic Solution
USP, 0.1%.
ANDA 074320................. Etoposide Injection, Hospira, Inc.
20 mg/mL.
ANDA 074351................. Etoposide Injection, Do.
20 mg/mL.
ANDA 074353................. Cimetidine HCl Luitpold
Injection USP. Pharmaceuticals,
Inc.
[[Page 33313]]
ANDA 074381................. Dobutamine Injection Baxter Healthcare
USP, 12.5 mg (base)/ Corp.
mL.
ANDA 074545................. Dobutamine Injection Luitpold
USP, 12.5 mg/mL. Pharmaceuticals,
Inc.
ANDA 074634................. Dobutamine Injection Hospira, Inc.
USP, 12.5 mg/mL.
ANDA 074643................. Minoxidil Topical Bausch & Lomb, Inc.
Solution, 2%.
ANDA 074743................. Minoxidil Topical Sight
Solution, 2%. Pharmaceuticals,
Inc., 7 Giralda
Farms, suite 1001,
Madison, NJ 07940.
ANDA 074824................. Atracurium Besylate Baxter Healthcare
Injection USP, 10 Corp.
mg/mL.
ANDA 074825................. Atracurium Besylate Do.
Injection USP, 10
mg/mL.
ANDA 075341................. Ketoconazole Tablets AAIPharma Service
USP, 200 mg. Corp., 2320
Scientific Park
Dr., Wilmington, NC
28405.
ANDA 075456................. Enalaprilat Hospira, Inc.
Injection, 1.25 mg/
mL.
ANDA 075542................. Amrinone (inamrinone Baxter Healthcare
injection USP) EQ 5 Corp.
mg/mL.
ANDA 076617................. Fluconazole in Hospira, Inc.
Sodium Chloride
0.9% Injection.
ANDA 076656................. Fenoldopam Mesylate Luitpold
Injection USP, EQ Pharmaceuticals,
10 mg (base)/mL. Inc.
ANDA 076695................. Ondansetron Hospira, Inc.
Injection USP, EQ 2
mg (base)/mL.
ANDA 076696................. Ondansetron Do.
Injection USP, EQ 2
mg (base)/mL.
ANDA 077065................. Terbinafine HCl Gedeon Richter PLC,
Tablets, EQ 250 mg c/o Gedeon Richter
(base). USA, Inc., 1200
East Ridgewood
Ave., Ridgewood, NJ
07450.
ANDA 077333................. Amlodipine Besylate Do.
Tablets, EQ 2.5 mg
(base), 5 mg
(base), and 10 mg
(base).
ANDA 077389................. Carboplatin Teva Parenteral
Injection. Medicines, Inc., 19
Hughes, Irvine, CA
92618.
ANDA 077392................. Lamotrigine Tablets, Roxane Laboratories,
25 mg, 100 mg, 150, Inc., 1809 Wilson
mg, and 200 mg. Rd., Columbus, OH
43228.
ANDA 077994................. Ironotecan HCl Sandoz, Inc., 2555
Injection. West Midway Blvd.,
Broomfield, CO
80038-0446.
ANDA 080416................. Procaine HCl Hospira, Inc.
Injection USP, 1%
and 2%.
ANDA 083346................. Isoproterenol HCl Do.
Injection USP, 0.2
mg/mL.
ANDA 084178................. Methyltestosterone KV Pharmaceutical
Tablets, 5 mg. Co., One Corporate
Woods Dr.,
Bridgeton, MO
63044.
ANDA 084179................. Methyltestosterone Do.
Tablets, 25 mg.
ANDA 084312................. Methyltestosterone Do.
Tablets, 10 mg.
ANDA 084767................. Dimenhydrinate Baxter Healthcare
Injection USP. Corp.
ANDA 085284................. Aminophylline KV Pharmaceutical
Tablets, 100 mg. Co.
ANDA 085285................. Secobarbital Sodium Do.
Capsules, 100 mg.
ANDA 085289................. Aminophylline Do.
Tablets, 200 mg.
ANDA 085363................. Acetaminophen and Do.
Codeine Phosphate
Tablets, 325 mg/45
mg.
ANDA 085384................. Triprolidine HCl Do.
Syrup, 1.25mg/5 mL.
ANDA 085385................. Promethazine HCl Do.
Syrup, 25 mg/5 mL.
ANDA 085388................. Promethazine HCl Do.
Syrup, 6.25 mg/5 mL.
ANDA 085466................. Brompheniramine Do.
Maleate Elixir, 2
mg/5 mL.
ANDA 085492................. Acetic Acid with Do.
Hydrocortisone Otic
Solution, 2%/1%.
ANDA 085493................. Acetic Acid Otic Do.
Solution, 2%.
ANDA 085551................. Hydroxyzine HCl Baxter Healthcare
Injection USP, 25 Corp.
mg/mL and 50 mg/mL.
ANDA 085621................. Diphenhydramine HCl KV Pharmaceutical
Elixir, 12.5 mg/5 Co.
mL.
ANDA 085810................. Prednisone Tablets, Do.
5 mg.
ANDA 086619................. Hydrocortisone Baxter Healthcare
Sodium Succinate Corp.
for Injection USP,
EQ 100 mg (base)/
Vial.
ANDA 086661................. Donnatal A.H. Robins Co., c/o
(phenobarbital, Wyeth
hyoscyamine Pharmaceuticals,
sulfate, atropine Inc., P.O. Box
sulfate, 8299, Philadelphia,
scopolamine (HBr)) PA 19101-8299.
Elixir.
ANDA 086676................. Donnatal Do.
(phenobarbital,
hyoscyamine
sulfate, atropine
sulfate,
scopolamine (HBr))
Tablets.
ANDA 086677................. Donnatal Do.
(phenobarbital,
hyoscyamine
sulfate, atropine
sulfate,
scopolamine (HBr))
Capsules.
ANDA 086797................. Novocain (procaine Hospira, Inc.
HCl injection USP)
10%.
ANDA 086906................. Methylprednisolone Elkins-Sinn, Inc., c/
Sodium Succinate o Baxter Healthcare
for Injection USP, Corp.
EQ 40 mg (base),
125 mg (base), 500
mg (base), and 1 g
(base) Vials.
ANDA 087239................. Aminophylline Do.
Injection USP, 25
mg/mL.
ANDA 087240................. Aminophylline Luitpold
Injection USP, 25 Pharmaceuticals,
mg/mL. Inc.
ANDA 087311................. Chlorthalidone KV Pharmaceutical
Tablets, 25 mg. Co.
ANDA 087312................. Chlorthalidone Do.
Tablets, 50 mg.
ANDA 087506................. Muro Opcon Bausch & Lomb, Inc.
(naphazoline HCl
ophthalmic solution
USP, 0.1%).
ANDA 087567................. Hydrocortisone Baxter Healthcare
Sodium Succinate Corp.
for Injection USP,
EQ 250 mg (base)/
Vial.
ANDA 087568................. Hydrocortisone Do.
Sodium Succinate
for Injection USP,
EQ 500 mg (base)/
Vial.
[[Page 33314]]
ANDA 087569................. Hydrocortisone Do.
Sodium Succinate
for Injection USP,
EQ 1 g (base)/Vial.
ANDA 087584................. Potassium Chloride Luitpold
for Injection Pharmaceuticals,
Concentrate USP. Inc.
ANDA 087601................. Aminophylline Hospira, Inc.
Injection USP, 25
mg/mL.
ANDA 087956................. Vitamin K1 Do.
(phytonadione
injection emulsion
USP), 10 mg/mL.
ANDA 088279................. Meperidine HCl Baxter Healthcare
Injection USP, 25 Corp.
mg/mL.
ANDA 088280................. Meperidine HCl Do.
Injection USP, 50
mg/mL.
ANDA 088281................. Meperidine HCl Do.
Injection USP, 75
mg/mL.
ANDA 088282................. Meperidine HCl Do.
Injection USP, 100
mg/mL.
ANDA 088326................. Lidocaine HCl Hospira, Inc.
Injection USP, 1.5%.
ANDA 088331................. Lidocaine HCl Do.
Injection USP, 2%.
ANDA 088368................. Lidocaine HCl Do.
Injection USP, 20%.
ANDA 088371................. Cyclophosphamide for Baxter Healthcare
Injection USP, 100 Corp.
mg/Vial.
ANDA 088372................. Cyclophosphamide for Do.
Injection USP, 200
mg/Vial.
ANDA 088373................. Cyclophosphamide for Do.
Injection USP, 500
mg/Vial.
ANDA 088374................. Cyclophosphamide for Do.
Injection USP, 1 g/
Vial.
ANDA 089649................. Lidocaine HCl and Hospira, Inc.
Epinephrine
Injection.
ANDA 089703................. Prochlorperazine Do.
Edisylate Injection
USP, EQ 5 mg (base)/
mL.
ANDA 089707................. Perphenazine Tablets Ivax Pharmaceuticals
USP, 2 mg. Inc., 400 Chestnut
Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 090954................. Cromolyn Sodium Oral Pack
Solution Pharmaceuticals,
Concentrate, 100 mg/ LLC, 1110 West Lake
5 mL. Cook Rd., suite
152, Buffalo Grove,
IL 60089.
------------------------------------------------------------------------
\1\ This product was an oral pressurized metered-dose inhaler that
contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
longer be used as a propellant for any metaproterenol sulfate or
fluticasone propionate metered-dose inhalers (see 75 FR 19213-19241,
April 14, 2010; 71 FR 70870-70873, December 7, 2006).
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner of Food and Drugs, approval of the applications listed
in table 1 of this document, and all amendments and supplements
thereto, is hereby withdrawn, effective July 8, 2011. Introduction or
delivery for introduction into interstate commerce of products without
approved new drug applications violates section 301(a) and (d) of the
FD&C Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in
table 1 of this document that are in inventory on the date that this
notice becomes effective (see the DATES section) may continue to be
dispensed until the inventories have been depleted or the drug products
have reached their expiration dates or otherwise become violative,
whichever occurs first.
Dated: May 31, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2011-14164 Filed 6-7-11; 8:45 am]
BILLING CODE 4160-01-P
