Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications, 43210-43214 [2013-17324]
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43210
Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices
held on October 25, 2012. In selecting
the disease areas, FDA carefully
considered the public comments
received and the perspectives of its
review divisions. By the end of FY 2015,
FDA will initiate another public process
for determining the disease areas for FY
2016–2017. More information, including
the list of disease areas and a general
schedule of meetings, is posted on
FDA’s Web site at https://www.fda.gov/
ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm326192.htm.
II. Public Meeting Information
emcdonald on DSK67QTVN1PROD with NOTICES
A. Purpose and Scope of the Meeting
As part of Patient-Focused Drug
Development, FDA will gather patient
and patient stakeholder input on
symptoms of narcolepsy that matter
most to patients and on current
approaches to treating narcolepsy.
Narcolepsy is a chronic disorder of the
central nervous system caused by the
brain’s inability to control sleep-wake
cycles and is characterized by excessive
daytime sleepiness, cataplexy,
hallucination, and disturbed nocturnal
sleep. Although there is no cure for
narcolepsy, medications and lifestyle
modifications can help patients manage
their symptoms. FDA is interested in
obtaining a better understanding of
patients’ perspectives on the severity of
the disease and assessments of available
therapies.
The questions that will be asked of
patients and patient stakeholders at the
meeting are listed in this section,
organized by topic. For each topic, a
brief patient panel discussion will begin
the dialogue, followed by a facilitated
discussion inviting comments from
other patient and patient stakeholder
participants. In addition to input
generated through this public meeting,
FDA is interested in receiving patient
input addressing these questions
through the public docket (see
ADDRESSES).
Topic 1: Disease symptoms and daily
impacts that matter most to patients:
1. Of all the symptoms that you
experience because of your condition,
which one to three symptoms have the
most significant impact on your life?
(Examples may include excessive
daytime sleepiness, cataplexy, etc.)
2. Are there specific activities that are
important to you but that you cannot do
at all or as fully as you would like
because of your condition? (Examples of
activities may include sleeping through
the night, work and school performance,
etc.)
3. How have your symptoms changed
over time?
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3.1. Do your symptoms come and go?
If so, do you know of anything that
makes your symptoms better? Worse?
Topic 2: Patients’ perspectives on
current approaches to treating
narcolepsy:
1. What are you currently doing to
help treat your condition or its
symptoms? (Examples may include
FDA-approved medicines, over-thecounter products, and other therapies
including non-drug therapies such as
lifestyle modifications.)
1.1. What specific symptoms do your
therapies address?
1.2. How has your treatment regimen
changed over time, and why?
2. How well does your current
treatment regimen treat the most
significant symptoms of your disease?
2.1. How well do these therapies
improve your ability to do specific
activities that are important to you in
your daily life?
2.2. How well have these therapies
worked for you as your condition has
changed over time?
3. What are the most significant
downsides to your current therapies,
and how do they affect your daily life?
(Examples of downsides may include
bothersome side effects, inconvenient
dosing schedules, access issues, etc.)
4. Assuming there is no complete cure
for your condition, what specific things
would you look for in an ideal therapy
for your condition?
Patients who are interested in
presenting comments as part of the
initial panel discussions will be asked
to indicate in their registration which
topic(s) they wish to address. They will
also be asked to send a brief summary
of responses to the topic questions to
PatientFocused@fda.hhs.gov. Panelists
will be notified of their selection soon
after the close of registration on
September 13, 2013. FDA will try to
accommodate all patients and patient
stakeholders who wish to speak, either
through the panel discussion or
audience participation; however, the
duration of comments may be limited by
time constraints.
Interested members of the public,
including those who attend the meeting
in person or through the webcast, are
invited to provide electronic or written
responses to the questions pertaining to
Topics 1 and 2 to the public docket (see
ADDRESSES). Comments may be
submitted until November 25, 2013.
B. Meeting Attendance and/or
Participation
If you wish to attend this meeting,
visit https://patientfocused
narcolepsy.eventbrite.com. Please
register by September 13, 2013. Those
who are unable to attend the meeting in
person can register to view a live
webcast of the meeting. You will be
asked to indicate in your registration
whether you plan to attend in person or
via the webcast. Your registration
should also contain your complete
contact information, including name,
title, affiliation, address, email address,
and phone number.
Seating will be limited, so early
registration is recommended.
Registration is free and will be on a firstcome, first-served basis. However, FDA
may limit the number of participants
from each organization based on space
limitations. Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the meeting will be based on space
availability. If you need special
accommodations because of disability,
please contact Pujita Vaidya (see FOR
FURTHER INFORMATION CONTACT) at least 7
days before the meeting.
[Docket No. FDA–2013–N–0845]
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Dated: July 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–17327 Filed 7–18–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Bracco Diagnostics et al.; Withdrawal
of Approval of 52 New Drug
Applications and 77 Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 52 new drug applications
(NDAs) and 77 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 August 19, 2013.
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
SUMMARY:
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Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices
table 1 in 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.
43211
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
TABLE 1
Application No.
Drug
Applicant
NDA 011620 ...............
Cardiografin (diatrizoate meglumine USP, 85%) Injection ..
NDA 012828 ...............
Travase (sutilains) Ointment ................................................
NDA 014215 ...............
Celestone (betamethasone) Oral Solution ..........................
NDA 014685 ...............
NDA 016019 ...............
Aventyl (nortriptyline hydrochloride (HCl) Oral Solution, 10
milligrams (mg)/5 milliliters (mL).
Aralen Phosphate (chloroquine phosphate) with primaquine phosphate Tablets.
Cloroquine-Primaquine (chloroquine phosphate and primaquine phosphate) Tablets.
Questran Resin (cholestyramine resin) ...............................
Bracco Diagnostics, 107 College Rd. East, Princeton, NJ
08540.
Abbott Laboratories, PA 77/Bldg. AP30–1E, 200 Abbott
Park Rd., Abbott Park, IL 60064–6157.
Merck Sharp & Dohme Corp., One Merck Dr., P.O. Box
100, Whitehouse Station, NJ 08889.
Ranbaxy Inc., U.S. Agent for Ranbaxy Laboratories Limited, 600 College Rd. East, Princeton, NJ 08540.
Sanofi-Aventis U.S., LLC, 55 Corporate Dr., Bridgewater,
NJ 08807–0890.
Do.
NDA 016640 ...............
NDA 016721 ...............
Questran Powder (cholestyramine for oral suspension) .....
Dalmane (flurazepam HCl) Capsules ..................................
NDA 016732 ...............
NDA 016891 ...............
Talwin 50 (pentazocine HCl USP), Tablets, 50 mg ............
Talwin Compound (pentazocine HCl USP and aspirin
USP), Equivalent to (EQ) 12.5 mg (base) and 325 mg.
Demulen 1/50–21 (ethynodiol diacetate/ethinyl estradiol)
Tablets.
Demulen 1/50–28 (ethynodiol diacetate/ethinyl estradiol)
Tablets.
Danocrine (danazol) Capsules ............................................
Glycine Irrigation USP, 1.5% ...............................................
Flexeril (cyclobenzaprine HCl) Tablets, 5 mg and 10 mg ...
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543–4000.
Do.
Valeant Pharmaceuticals North America, LLC, 700 Route
202/206 North, Bridgewater, NJ 08807.
Sanofi-Aventis U.S., LLC.
Do.
G.D. Searle, LLC, c/o Pfizer Inc., 235 East 42nd St., New
York, NY 10017.
Do.
NDA 014860 ...............
NDA 016017 ...............
NDA 016927 ...............
NDA 016936 ...............
NDA 017557 ...............
NDA 017633 ...............
NDA 017821 ...............
NDA 017850 ...............
NDA 017857 ...............
NDA 018160 ...............
NDA 018168 ...............
ANDA 018398 .............
NDA 018458 ...............
ANDA 018581 .............
NDA 018733 ...............
NDA 018981 ...............
NDA 019057 ...............
NDA 019436 ...............
NDA 019507 ...............
NDA 019578 ...............
NDA 019669 ...............
NDA 019807 ...............
NDA 019977 ...............
emcdonald on DSK67QTVN1PROD with NOTICES
NDA 020036 ...............
NDA 020038 ...............
NDA 020056 ...............
NDA 020070 ...............
NDA 020095 ...............
NDA 020151 ...............
NDA 020239 ...............
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Klotrix (potassium chloride) Extended-Release Tablets .....
Stadol (butorphanol tartrate USP) Injection ........................
Demulen 1/35–28 (ethynodiol diacetate/ethinyl estradiol)
Tablets.
Demulen 1/35–21 (ethynodiol diacetate/ethinyl estradiol)
Tablets.
Dopamine HCl Injection USP, 40 mg/mL and 80 mg/mL ...
Talacen (pentazocine HCl USP and acetaminophen USP),
Tablets, EQ 25 mg (base) and 650 mg.
Sodium Nitroprusside for Injection USP, 50 mg/vial ...........
Talwin Nx (pentazocine HCl and naloxone HCl) Tablets,
50 mg and 0.5 mg.
Enkaid (encainide HCl) Capsules ........................................
Hytrin (terazosin HCl) Tablets, 1 mg, 2 mg, 5 mg, and 10
mg.
Primacor (milrinone lactate) Injection, EQ 1 mg (base)/mL
Kerlone (betaxolol HCl) Tablets, 10 mg and 20 mg ...........
Mefloquine HCl Tablets, 250 mg .........................................
Questran Light, Questran II, and Questran Sugar Free
(cholestyramine for oral suspension).
Kerledex (betaxolol HCl and chlorthalidone) Tablets ..........
Oramorph SR (morphine sulfate) Sustained-Release Tablets, 15 mg, 30 mg, 60 mg, and 100 mg.
Aredia (pamidronate disodium) for injection, 30 mg, 60
mg, and 90 mg.
Fludara (fludarabine phosphate) for Injection, 50 mg/vial ...
Atropine Sulfate Aerosol for Inhalation ................................
Cognex (tacrine HCl) Capsules, 10 mg, 20 mg, 30 mg,
and 40 mg.
Zantac (ranitidine HCl) Geldose Capsules ..........................
Effexor (venlafaxine HCl) Tablets, 12.5 mg, 25 mg, 37.5
mg, 50 mg, 75 mg, and 100 mg.
Kytril (granisetron HCl) Injection, EQ 1 mg (base)/mL and
0.1 mg (base)/mL, 1 mg (base)/mL, and 3 mg (base)/
mL.
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Sanofi-Aventis U.S., LLC.
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
Janssen Research & Development, LLC, 1125 TrentonHarbourton Rd., Titusville, NJ 08560.
Bristol-Myers Squibb Co.
Do.
G.D. Searle, LLC, c/o Pfizer Inc.
Do.
Baxter Healthcare Corp., 25212 W. Illinois Route 120,
Round Lake, IL 60073.
Sanofi-Aventis U.S., LLC.
Baxter Healthcare Corp.
Sanofi-Aventis U.S., LLC.
Bristol-Myers Squibb Co.
Abbott Laboratories.
Sanofi-Aventis U.S., LLC.
Do.
U.S. Army Office of the Surgeon General, Department of
the Army, 1430 Veterans Dr., Fort Detrick, MD 21702–
5009.
Bristol-Myers Squibb Co.
Sanofi-Aventis U.S., LLC.
Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071.
Novartis Pharmacueticals Corp., One Health Plaza, East
Hanover, NJ 07936–1080.
Genzyme Corp., 500 Kendall St., Cambridge, MA 02142.
U.S. Army Office of the Surgeon General.
Shionogi Inc., 300 Campus Dr., Florham Park, NJ 07932.
GlaxoSmithKline, P.O. Box 13398, 5 Moore Dr., Research
Triangle Park, NC 27709.
Wyeth Pharmaceuticals, Inc., 235 East 42nd St., New
York, NY 10017.
Hoffman-La Roche, Inc., c/o Genentech, Inc., 1 DNA Way,
South San Francisco, CA 94080.
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Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices
TABLE 1—Continued
Application No.
Drug
NDA 020305 ...............
Kytril (granisetron HCl) Tablets, EQ 1 mg (base), EQ 2
mg (base).
DynaCirc CR (isradipine) Controlled-Release Tablets ........
NDA 020336 ...............
NDA 020343 ...............
NDA 020347 ...............
Applicant
NDA 020441 ...............
Primacor (milrinone lactate) Injection ..................................
Hytrin (terazosin HCl) Capsules, 1 mg, 2 mg, 5, mg, and
10 mg.
Pulmicort Turbuhaler (budesonide) Inhalation Powder .......
NDA 020484 ...............
Innohep (tinzaparin sodium) Injection .................................
NDA 020611 ...............
Dovonex (calcipotriene) Topical Solution, 0.005% ..............
NDA 020680 ...............
NDA 021238 ...............
NDA 021320 ...............
Norvir (ritonavir) Capsules, 100 mg ....................................
Kytril (granisetron HCl) Oral Solution, 2 mg/10 mL ............
Plenaxis (abarelix) Injection, 100 mg/vial ............................
NDA 021744 ...............
NDA 022021 ...............
Proquin XR (ciprofloxacin HCl) Tablets, 500 mg ................
Altace (ramipril) Tablets, 1.25 mg, 2.5 mg, 5 mg, and 10
mg.
Amlodipine Besylate Orally Disintegrating Tablets, 2.5 mg,
5 mg, and 10 mg.
Omeprazole, Sodium Bicarbonate, and Magnesium Hydroxide Tablets.
Neosar (cyclophosphamide) for Injection, 100 mg, 200
mg, 500 mg, 1 gram (gm), and 2 gm vials.
Thiamine HCl Injection USP, 100 mg/mL ...........................
Edrophonium Chloride Injection, 10 mg/mL ........................
Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg
NDA 022026 ...............
NDA 022456 ...............
ANDA 040015 .............
ANDA 040079 .............
ANDA 040131 .............
ANDA 040162 .............
ANDA 040272 .............
Oxycodone and Acetaminophen Tablets USP, 5 mg/325
mg.
ANDA 040332 .............
ANDA 040364 .............
Leucovorin Calcium Injection USP, 10 mg (base) ..............
Prednisolone Syrup, 15 mg/5 mL ........................................
ANDA
ANDA
ANDA
ANDA
Hydralazine HCl Injection USP, 20 mg/mL .........................
Prednisolone Syrup, 5 mg/5 mL ..........................................
Prochlorperazine Edisylate Injection USP, 5 mg/mL ..........
Methylprednisolone Sodium Succinate for Injection USP,
125 mg/vial, 500 mg/vial, and 1 gm/vial.
Methylprednisolone Sodium Succinate for Injection USP,
40 mg/vial.
Methylprednisolone Sodium Succinate for Injection USP,
500 mg/vial and 1 gm/vial.
Benzonatate Capsules USP, 100 mg and 200 mg .............
Sodium Polystyrene Sulfonate Powder for Suspension,
454 gm/bottle.
Declomycin (demeclocycline HCl) Tablets, 75 mg, 150
mg, and 300 mg.
V-Cillin K (pencillin V potassium tablets USP), 125 mg,
250 mg, and 500 mg.
Fugizone (amphotericin B) for Injection ..............................
Mycostatin (nystatin) Cream, 100,000 units/gm ..................
Kantrex (kanamycin sulfate injection USP) Injection,75
mg/2 mL, 500 mg/2 mL, and 1 gm/3 mL.
Nebcin (tobramycin for injection USP) ................................
Amikin (amikacin sulfate injection USP), 50 mg/mL and
250 mg/mL.
Nebcin (tobramycin for injection USP) ................................
Clindamycin Injection USP ..................................................
Tobramycin Injection USP ...................................................
Gentamicin Injection USP, 10 mg/mL .................................
Clindamycin Phosphate Injection, EQ 150 mg (base)/mL ..
Erythromycin Lactobionate for Injection USP, 500 mg
(base)/vial and 1 gm (base)/vial.
Tobramycin Sulfate Injection ...............................................
Amphotericin B for Injection USP, 50 mg/vial .....................
Daunorubicin HCl for Injection USP, 20 mg (base)/vial and
50 mg (base)/vial.
040373
040423
040505
040641
.............
.............
.............
.............
ANDA 040662 .............
ANDA 040709 .............
ANDA 040795 .............
ANDA 040909 .............
NDA 050261 ...............
ANDA 060003 .............
ANDA 060517 .............
ANDA 060575 .............
ANDA 061901 .............
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ANDA 062008 .............
ANDA 062311 .............
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
062707
063041
063080
063149
063282
063253
.............
.............
.............
.............
.............
.............
ANDA 064021 .............
.................................
ANDA 064212 .............
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GlaxoSmithKline, 2301 Renaissance Blvd., King of Prussia, PA 19406.
Sanofi-Aventis U.S., LLC.
Abbott Laboratories.
AstraZeneca, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803–8355.
LEO Pharma A/S, c/o Parexel International Corp., 4600
East-West Highway, Suite 350, Bethesda, MD 20814.
LEO Pharma A/S, c/o LEO Pharma Inc., 1 Sylvan Way,
Parsippany, NJ 07054.
Abbott Laboratories.
Hoffman-La Roche, Inc., c/o Genentech, Inc.
Specialty European Pharma Limited, c/o Strategic Bioscience Corp., 93 Birch Hill Rd., Stow, MA 01775.
Depomed Inc., 1360 O’Brien Dr., Menlo Park, CA 94025.
King Pharmaceuticals Inc., c/o Pfizer Inc., 235 East 42nd
St., New York, NY 10017.
Synthon Pharmaceuticals, Inc., 9000 Development Dr.,
P.O. Box 110487, Research Triangle Park, NC 27709.
Santarus, Inc., 3721 Valley Centre Dr., Suite 400, San
Diego, CA 92130.
Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA
92618.
Hospira, Inc.
Do.
IVAX Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake,
NJ 07677.
Duramed Pharmaceuticals, Inc., Subsidiary of Barr Laboratories, Inc., Indirect Wholly Owned Subsidiary of
Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd.,
Woodcliff Lake, NJ 07677.
Teva Parenteral Medicines, Inc.
Nesher Pharmaceuticals (USA) LLC, 13910 Saint Charles
Rock Rd., Bridgton, MO 63044.
Teva Parenteral Medicines, Inc.
Nesher Pharmaceuticals (USA) LLC.
Teva Parenteral Medicines, Inc.
Bedford Laboratories, 300 Northfield Rd., Bedford, OH
44146.
Do.
Do.
Nesher Pharmaceuticals (USA) LLC.
Citrus Pharma, LLC, 3940 Quebec Ave. North, Minneapolis, MN 55427.
CorePharma, LLC, 215 Wood Ave., Middllesex, NJ
08846–2554.
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN
46285.
Bristol-Myers Squibb Co.
Do.
Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO
80038–0446.
Eli Lilly and Co.
Brisol-Myers Squibb Co.
Eli Lilly and Co.
Teva Parenteral Medicines, Inc.
Hospira, Inc.
Teva Parenteral Medicines, Inc.
Do.
Do.
Bristol-Myers Squibb Co.
Teva Parenteral Medicines, Inc.
Do.
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43213
TABLE 1—Continued
Application No.
Drug
ANDA 065037 .............
ANDA 065321 .............
ANDA 065433 .............
Idarubicin HCl for Injection USP, 5 mg/vial, 10 mg/vial,
and 20 mg/vial.
Nystatin Topical Powder USP, 100,000 units/gm ...............
Mycophenolate Mofetil Capsules, 250 mg ..........................
ANDA 065477 .............
ANDA 070159 .............
Mycophenolate Mofetil Tablets, 500 mg .............................
Tolazamide Tablets USP, 100 mg ......................................
ANDA
ANDA
ANDA
ANDA
ANDA
.............
.............
.............
.............
.............
Tolazamide Tablets USP, 250 mg ......................................
Tolazamide Tablets USP, 500 mg ......................................
Valproic Acid Capsules, 250 mg .........................................
Verapamil HCl Injection USP, 2.5 mg/mL ...........................
Ibuprofen Tablets USP, 400 mg ..........................................
ANDA 070980 .............
ANDA 071726 .............
Potassium Chloride Extended-Release Capsules USP, 10
milliequivalents.
Disopyramide Phosphate Extended-Release Capsules
USP, 150 mg.
Metaproterenol Sulfate Inhalation Solution, 0.6% ...............
ANDA 071855 .............
ANDA 072273 .............
Metaproterenol Sulfate Inhalation Solution, 0.4% ...............
Albuterol Inhalation Aerosol1 ...............................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
.............
.............
.............
.............
.............
.............
.............
.............
Fenoprofen Calcium Capsules USP, 200 mg .....................
Methyldopate HCl Injection USP .........................................
Dopamine HCl Injection USP, 80 mg/mL ............................
Metoclopramine Injection USP, 5 mg/mL ............................
Sodium Nitroprusside Injection, 25 mg/mL .........................
Pentamidine Isethionate for Injection, 300 mg/vial .............
Cyclobenzaprine HCl Tablets, 10 mg ..................................
Pindolol Tablets USP, 5 mg ................................................
ANDA 074018 .............
ANDA 074105 .............
Pindolol Tablets USP, 10 mg ..............................................
Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg .....
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
074147
074206
074252
074519
074613
074616
074629
074637
074753
074768
.............
.............
.............
.............
.............
.............
.............
.............
.............
.............
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
074784
074795
074969
075004
075005
075012
075071
075119
.............
.............
.............
.............
.............
.............
.............
.............
Metoclopramide Injection USP, 5 mg/mL ............................
Dobutamine Injection USP, 250 mg (base)/20 mL .............
Cimetidine HCl Injection, EQ 300 mg (base)/2 mL .............
Captopril Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg ....
Bumetanide Injection USP, 0.25 mg/mL .............................
Inamrinone Lactate Injection, 5 mg/mL ...............................
Iopamidol Injection USP, 41%, 51%, 61%, and 76% .........
Iopamidol Injection USP, 61% .............................................
Atracurium Besylate Injection USP, 10 mg/mL (preserved)
Atracurium Besylate Injection USP, 10 mg/mL (preservative free).
Atracurium Besylate Injection USP, 10 mg/mL ...................
Fluphenazine Decanoate Injection USP, 25 mg/mL ...........
Acyclovir for Injection USP, 500 mg/vial and 1,000 mg/vial
Diltiazem HCl Injection, 5 mg/mL ........................................
Iopamidol Injection USP, 51%, 61%, and 76% ...................
Etodolac Tablets USP, 400 mg and 500 mg ......................
Etodolac Capsules, 200 mg and 300 mg ............................
Buspirone HCl Tablet USP, 5 mg, 10 mg, and 15 mg .......
070160
070161
070431
070577
070818
ANDA 071200 .............
072437
072974
073000
073117
073465
073617
073683
074013
Applicant
NDA 075166 ...............
Isosorbide Mononitrate Extended-Release Tablets, 60 mg
ANDA 075328 .............
Pemoline Tablets, 18.75 mg, 37.5 mg, and 75 mg .............
ANDA 075392 .............
Propofol Injectable Emulsion, 10 mg/mL .............................
Do.
Nesher Pharmaceuticals (USA) LLC.
Zydus Pharmaceuticals (USA) Inc., 73 Route 31 North,
Pennington, NJ 08534.
Do.
Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring
Valley, NY 10977.
Do.
Do.
Do.
Hospira, Inc.
Ohm Laboratories, c/o Ranbaxy Inc., 600 College Rd.
East, Princeton, NJ 08540.
Nesher Pharmaceuticals (USA) LLC.
Do.
Nephron Pharmaceuticals Corp., 4121 South West 34th
St., Orlando, FL 32811.
Do.
Armstrong Pharmaceuticals, Inc. 25 John Rd., Canton,
MA 02021.
Par Pharmaceuticals, Inc.
Teva Parenteral Medicines, Inc.
Do.
Hospira, Inc.
Teva Parenteral Medicines, Inc.
Baxter Healthcare Corp.
Sandoz Inc.
Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd.,
P.O. Box 4310, Morgantown, WV 26505–4310.
Do.
DAVA Pharmaceuticals, Inc., Parker Plaza, 400 Kelby St.,
10th Floor, Fort Lee, NJ 07024.
Hospira, Inc.
Teva Parenteral Medicines, Inc.
Do.
Sandoz Inc.
Teva Parenteral Medicines, Inc.
Hospira, Inc.
Baxter Healthcare Corp.
Hospira, Inc.
Baxter Healthcare Corp.
Do.
Teva Parenteral Medicines, Inc.
Do.
Do.
Hospira, Inc.
Do.
Mylan Pharmaceuticals, Inc.
Do.
Egis Pharmaceuticals PLC, c/o GlobePharm Inc., 313
Pine St., Suite 204, Deerfield, IL 60015.
SkyePharma AG, c/o Compliance Resources, LLC, 7100
Farmington Lane, Hillsborough, NC 27278.
Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL
35811.
Teva Parenteral Medicines, Inc.
1 This
emcdonald on DSK67QTVN1PROD with NOTICES
product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
longer be used as a propellant for any albuterol metered-dose inhalers (see 70 FR 17168, April 4, 2005).
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(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,
VerDate Mar<15>2010
15:33 Jul 18, 2013
Jkt 229001
approval of the applications listed in
table 1 in this document, and all
amendments and supplements thereto,
is hereby withdrawn, effective August
19, 2013. Introduction or delivery for
introduction into interstate commerce of
PO 00000
Frm 00074
Fmt 4703
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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 that are in inventory on the date
that this notice becomes effective (see
E:\FR\FM\19JYN1.SGM
19JYN1
43214
Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices
DATES)
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Eileen Newman,
Associate Director, National Kidney
Disease Education Program, OCPL,
NIDDK, NIH, Building 31, Room 9A06,
9000 Rockville Pike, Bethesda, MD
20892, or call non-toll-free number 301–
435–8116 or Email your request,
including your address to:
Eileen.newman@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Evaluation of a
Kidney Disease Education Program with
Promotores in the Hispanic Community,
0925–NEW, National Kidney Disease
Education Program, National Institute of
Diabetes and Digestive and Kidney
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: July 15, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2013–17324 Filed 7–18–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment
Request Evaluation of a Kidney
Disease Education and Awareness
Program in the Hispanic Community
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Kidney Disease Education
Program, the National Institute of
Diabetes and Digestive and Kidney
Diseases, the National Institutes of
Health (NIH), will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
SUMMARY:
Diseases (NIDDK), National Institutes of
Health (NIH).
Need and Use of Information
Collection: NKDEP is developing a
kidney disease education program to
raise awareness among the Hispanic
community at risk for kidney disease.
Since diabetes is the most common
cause of kidney disease, the program is
being developed for inclusion in
existing diabetes programs being
conducted by ‘‘promotores de salud’’
(Spanish/English-speaking community
health workers). A pilot evaluation will
assess: (a) Overall quality of the program
from the client and promotor/a
perspective, including strengths and
weaknesses of the program and the
training, and areas for program
improvement; (b) effectiveness of the
program on the clients (the community
members being educated); and (c)
effectiveness of materials and training,
including promotores’ ability to deliver
education to the client and administer
the client pre-test/post-test surveys. The
pilot study will deliver strategic and
actionable guidance for refining the
educational and training materials for
national dissemination. Based on
outcomes from the pilot study, a
national evaluation is planned that will
use the client pre-test/post-test surveys
to assess: (a) Knowledge gains about
kidney disease, (b) awareness of NKDEP
resources and importance of kidney
health, (c) reported behavior change
outcomes and (d) reported health status.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
101 (see table below).
TABLE A.12.A—ESTIMATE ANNUALIZED BURDEN HOURS
Type of respondent
Pilot study collection:
Promotores ................................
Promotores ................................
emcdonald on DSK67QTVN1PROD with NOTICES
Client Group ...............................
Client Group (partial) .................
Total ....................................
VerDate Mar<15>2010
15:33 Jul 18, 2013
Number of
responses per
respondent
Number of
respondents
Form name
Response
burden
(hours)
Total
burden
hours
Promotores training pre-test, posttest, and qualitative in-depth interview post client session (Attachment 1 and 2).
Administer client pre-test, post-test,
and second post-tests for experimental and control groups (Attachment 3).
Client pre-test, post-test, second
post-test for experimental and
control groups (Attachment 3).
Client qualitative in-depth interview
post-client session (Attachment 4).
12
1
5/60
1
20
17
15/60
85
85
1
10/60
14
4
1
10/60
1
...........................................................
121
........................
........................
101
Jkt 229001
PO 00000
Frm 00075
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E:\FR\FM\19JYN1.SGM
19JYN1
]]>Agencies
[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43210-43214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17324]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0845]
Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug
Applications and 77 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 52 new drug applications (NDAs) and 77 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 August 19, 2013.
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
[[Page 43211]]
table 1 in 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 011620................. Cardiografin Bracco Diagnostics,
(diatrizoate 107 College Rd.
meglumine USP, 85%) East, Princeton, NJ
Injection. 08540.
NDA 012828................. Travase (sutilains) Abbott Laboratories,
Ointment. PA 77/Bldg. AP30-
1E, 200 Abbott Park
Rd., Abbott Park,
IL 60064-6157.
NDA 014215................. Celestone Merck Sharp & Dohme
(betamethasone) Oral Corp., One Merck
Solution. Dr., P.O. Box 100,
Whitehouse Station,
NJ 08889.
NDA 014685................. Aventyl Ranbaxy Inc., U.S.
(nortriptyline Agent for Ranbaxy
hydrochloride (HCl) Laboratories
Oral Solution, 10 Limited, 600
milligrams (mg)/5 College Rd. East,
milliliters (mL). Princeton, NJ
08540.
NDA 014860................. Aralen Phosphate Sanofi-Aventis U.S.,
(chloroquine LLC, 55 Corporate
phosphate) with Dr., Bridgewater,
primaquine phosphate NJ 08807-0890.
Tablets.
NDA 016017................. Cloroquine-Primaquine Do.
(chloroquine
phosphate and
primaquine
phosphate) Tablets.
NDA 016019................. Questran Resin Bristol-Myers Squibb
(cholestyramine Co., P.O. Box 4000,
resin). Princeton, NJ 08543-
4000.
NDA 016640................. Questran Powder Do.
(cholestyramine for
oral suspension).
NDA 016721................. Dalmane (flurazepam Valeant
HCl) Capsules. Pharmaceuticals
North America, LLC,
700 Route 202/206
North, Bridgewater,
NJ 08807.
NDA 016732................. Talwin 50 Sanofi-Aventis U.S.,
(pentazocine HCl LLC.
USP), Tablets, 50 mg.
NDA 016891................. Talwin Compound Do.
(pentazocine HCl USP
and aspirin USP),
Equivalent to (EQ)
12.5 mg (base) and
325 mg.
NDA 016927................. Demulen 1/50-21 G.D. Searle, LLC, c/
(ethynodiol o Pfizer Inc., 235
diacetate/ethinyl East 42nd St., New
estradiol) Tablets. York, NY 10017.
NDA 016936................. Demulen 1/50-28 Do.
(ethynodiol
diacetate/ethinyl
estradiol) Tablets.
NDA 017557................. Danocrine (danazol) Sanofi-Aventis U.S.,
Capsules. LLC.
NDA 017633................. Glycine Irrigation Hospira, Inc., 275
USP, 1.5%. North Field Dr.,
Lake Forest, IL
60045.
NDA 017821................. Flexeril Janssen Research &
(cyclobenzaprine Development, LLC,
HCl) Tablets, 5 mg 1125 Trenton-
and 10 mg. Harbourton Rd.,
Titusville, NJ
08560.
NDA 017850................. Klotrix (potassium Bristol-Myers Squibb
chloride) Extended- Co.
Release Tablets.
NDA 017857................. Stadol (butorphanol Do.
tartrate USP)
Injection.
NDA 018160................. Demulen 1/35-28 G.D. Searle, LLC, c/
(ethynodiol o Pfizer Inc.
diacetate/ethinyl
estradiol) Tablets.
NDA 018168................. Demulen 1/35-21 Do.
(ethynodiol
diacetate/ethinyl
estradiol) Tablets.
ANDA 018398................ Dopamine HCl Baxter Healthcare
Injection USP, 40 mg/ Corp., 25212 W.
mL and 80 mg/mL. Illinois Route 120,
Round Lake, IL
60073.
NDA 018458................. Talacen (pentazocine Sanofi-Aventis U.S.,
HCl USP and LLC.
acetaminophen USP),
Tablets, EQ 25 mg
(base) and 650 mg.
ANDA 018581................ Sodium Nitroprusside Baxter Healthcare
for Injection USP, Corp.
50 mg/vial.
NDA 018733................. Talwin Nx Sanofi-Aventis U.S.,
(pentazocine HCl and LLC.
naloxone HCl)
Tablets, 50 mg and
0.5 mg.
NDA 018981................. Enkaid (encainide Bristol-Myers Squibb
HCl) Capsules. Co.
NDA 019057................. Hytrin (terazosin Abbott Laboratories.
HCl) Tablets, 1 mg,
2 mg, 5 mg, and 10
mg.
NDA 019436................. Primacor (milrinone Sanofi-Aventis U.S.,
lactate) Injection, LLC.
EQ 1 mg (base)/mL.
NDA 019507................. Kerlone (betaxolol Do.
HCl) Tablets, 10 mg
and 20 mg.
NDA 019578................. Mefloquine HCl U.S. Army Office of
Tablets, 250 mg. the Surgeon
General, Department
of the Army, 1430
Veterans Dr., Fort
Detrick, MD 21702-
5009.
NDA 019669................. Questran Light, Bristol-Myers Squibb
Questran II, and Co.
Questran Sugar Free
(cholestyramine for
oral suspension).
NDA 019807................. Kerledex (betaxolol Sanofi-Aventis U.S.,
HCl and LLC.
chlorthalidone)
Tablets.
NDA 019977................. Oramorph SR (morphine Xanodyne
sulfate) Sustained- Pharmaceuticals,
Release Tablets, 15 Inc., One
mg, 30 mg, 60 mg, Riverfront Pl.,
and 100 mg. Newport, KY 41071.
NDA 020036................. Aredia (pamidronate Novartis
disodium) for Pharmacueticals
injection, 30 mg, 60 Corp., One Health
mg, and 90 mg. Plaza, East
Hanover, NJ 07936-
1080.
NDA 020038................. Fludara (fludarabine Genzyme Corp., 500
phosphate) for Kendall St.,
Injection, 50 mg/ Cambridge, MA
vial. 02142.
NDA 020056................. Atropine Sulfate U.S. Army Office of
Aerosol for the Surgeon
Inhalation. General.
NDA 020070................. Cognex (tacrine HCl) Shionogi Inc., 300
Capsules, 10 mg, 20 Campus Dr., Florham
mg, 30 mg, and 40 mg. Park, NJ 07932.
NDA 020095................. Zantac (ranitidine GlaxoSmithKline,
HCl) Geldose P.O. Box 13398, 5
Capsules. Moore Dr., Research
Triangle Park, NC
27709.
NDA 020151................. Effexor (venlafaxine Wyeth
HCl) Tablets, 12.5 Pharmaceuticals,
mg, 25 mg, 37.5 mg, Inc., 235 East 42nd
50 mg, 75 mg, and St., New York, NY
100 mg. 10017.
NDA 020239................. Kytril (granisetron Hoffman-La Roche,
HCl) Injection, EQ 1 Inc., c/o
mg (base)/mL and 0.1 Genentech, Inc., 1
mg (base)/mL, 1 mg DNA Way, South San
(base)/mL, and 3 mg Francisco, CA
(base)/mL. 94080.
[[Page 43212]]
NDA 020305................. Kytril (granisetron Do.
HCl) Tablets, EQ 1
mg (base), EQ 2 mg
(base).
NDA 020336................. DynaCirc CR GlaxoSmithKline,
(isradipine) 2301 Renaissance
Controlled-Release Blvd., King of
Tablets. Prussia, PA 19406.
NDA 020343................. Primacor (milrinone Sanofi-Aventis U.S.,
lactate) Injection. LLC.
NDA 020347................. Hytrin (terazosin Abbott Laboratories.
HCl) Capsules, 1 mg,
2 mg, 5, mg, and 10
mg.
NDA 020441................. Pulmicort Turbuhaler AstraZeneca, 1800
(budesonide) Concord Pike, P.O.
Inhalation Powder. Box 8355,
Wilmington, DE
19803-8355.
NDA 020484................. Innohep (tinzaparin LEO Pharma A/S, c/o
sodium) Injection. Parexel
International
Corp., 4600 East-
West Highway, Suite
350, Bethesda, MD
20814.
NDA 020611................. Dovonex LEO Pharma A/S, c/o
(calcipotriene) LEO Pharma Inc., 1
Topical Solution, Sylvan Way,
0.005%. Parsippany, NJ
07054.
NDA 020680................. Norvir (ritonavir) Abbott Laboratories.
Capsules, 100 mg.
NDA 021238................. Kytril (granisetron Hoffman-La Roche,
HCl) Oral Solution, Inc., c/o
2 mg/10 mL. Genentech, Inc.
NDA 021320................. Plenaxis (abarelix) Specialty European
Injection, 100 mg/ Pharma Limited, c/o
vial. Strategic
Bioscience Corp.,
93 Birch Hill Rd.,
Stow, MA 01775.
NDA 021744................. Proquin XR Depomed Inc., 1360
(ciprofloxacin HCl) O'Brien Dr., Menlo
Tablets, 500 mg. Park, CA 94025.
NDA 022021................. Altace (ramipril) King Pharmaceuticals
Tablets, 1.25 mg, Inc., c/o Pfizer
2.5 mg, 5 mg, and 10 Inc., 235 East 42nd
mg. St., New York, NY
10017.
NDA 022026................. Amlodipine Besylate Synthon
Orally Pharmaceuticals,
Disintegrating Inc., 9000
Tablets, 2.5 mg, 5 Development Dr.,
mg, and 10 mg. P.O. Box 110487,
Research Triangle
Park, NC 27709.
NDA 022456................. Omeprazole, Sodium Santarus, Inc., 3721
Bicarbonate, and Valley Centre Dr.,
Magnesium Hydroxide Suite 400, San
Tablets. Diego, CA 92130.
ANDA 040015................ Neosar Teva Parenteral
(cyclophosphamide) Medicines, Inc., 19
for Injection, 100 Hughes, Irvine, CA
mg, 200 mg, 500 mg, 92618.
1 gram (gm), and 2
gm vials.
ANDA 040079................ Thiamine HCl Hospira, Inc.
Injection USP, 100
mg/mL.
ANDA 040131................ Edrophonium Chloride Do.
Injection, 10 mg/mL.
ANDA 040162................ Prochlorperazine IVAX
Maleate Tablets USP, Pharmaceuticals,
5 mg and 10 mg. Inc., Subsidiary of
Teva
Pharmaceuticals
USA, 400 Chestnut
Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 040272................ Oxycodone and Duramed
Acetaminophen Pharmaceuticals,
Tablets USP, 5 mg/ Inc., Subsidiary of
325 mg. Barr Laboratories,
Inc., Indirect
Wholly Owned
Subsidiary of Teva
Pharmaceuticals
USA, 400 Chestnut
Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 040332................ Leucovorin Calcium Teva Parenteral
Injection USP, 10 mg Medicines, Inc.
(base).
ANDA 040364................ Prednisolone Syrup, Nesher
15 mg/5 mL. Pharmaceuticals
(USA) LLC, 13910
Saint Charles Rock
Rd., Bridgton, MO
63044.
ANDA 040373................ Hydralazine HCl Teva Parenteral
Injection USP, 20 mg/ Medicines, Inc.
mL.
ANDA 040423................ Prednisolone Syrup, 5 Nesher
mg/5 mL. Pharmaceuticals
(USA) LLC.
ANDA 040505................ Prochlorperazine Teva Parenteral
Edisylate Injection Medicines, Inc.
USP, 5 mg/mL.
ANDA 040641................ Methylprednisolone Bedford
Sodium Succinate for Laboratories, 300
Injection USP, 125 Northfield Rd.,
mg/vial, 500 mg/ Bedford, OH 44146.
vial, and 1 gm/vial.
ANDA 040662................ Methylprednisolone Do.
Sodium Succinate for
Injection USP, 40 mg/
vial.
ANDA 040709................ Methylprednisolone Do.
Sodium Succinate for
Injection USP, 500
mg/vial and 1 gm/
vial.
ANDA 040795................ Benzonatate Capsules Nesher
USP, 100 mg and 200 Pharmaceuticals
mg. (USA) LLC.
ANDA 040909................ Sodium Polystyrene Citrus Pharma, LLC,
Sulfonate Powder for 3940 Quebec Ave.
Suspension, 454 gm/ North, Minneapolis,
bottle. MN 55427.
NDA 050261................. Declomycin CorePharma, LLC, 215
(demeclocycline HCl) Wood Ave.,
Tablets, 75 mg, 150 Middllesex, NJ
mg, and 300 mg. 08846-2554.
ANDA 060003................ V-Cillin K (pencillin Eli Lilly and Co.,
V potassium tablets Lilly Corporate
USP), 125 mg, 250 Center,
mg, and 500 mg. Indianapolis, IN
46285.
ANDA 060517................ Fugizone Bristol-Myers Squibb
(amphotericin B) for Co.
Injection.
ANDA 060575................ Mycostatin (nystatin) Do.
Cream, 100,000 units/
gm.
ANDA 061901................ Kantrex (kanamycin Sandoz Inc., 2555 W.
sulfate injection Midway Blvd.,
USP) Injection,75 mg/ Broomfield, CO
2 mL, 500 mg/2 mL, 80038-0446.
and 1 gm/3 mL.
ANDA 062008................ Nebcin (tobramycin Eli Lilly and Co.
for injection USP).
ANDA 062311................ Amikin (amikacin Brisol-Myers Squibb
sulfate injection Co.
USP), 50 mg/mL and
250 mg/mL.
ANDA 062707................ Nebcin (tobramycin Eli Lilly and Co.
for injection USP).
ANDA 063041................ Clindamycin Injection Teva Parenteral
USP. Medicines, Inc.
ANDA 063080................ Tobramycin Injection Hospira, Inc.
USP.
ANDA 063149................ Gentamicin Injection Teva Parenteral
USP, 10 mg/mL. Medicines, Inc.
ANDA 063282................ Clindamycin Phosphate Do.
Injection, EQ 150 mg
(base)/mL.
ANDA 063253................ Erythromycin Do.
Lactobionate for
Injection USP, 500
mg (base)/vial and 1
gm (base)/vial.
ANDA 064021................ Tobramycin Sulfate Bristol-Myers Squibb
Injection. Co.
Amphotericin B for Teva Parenteral
Injection USP, 50 mg/ Medicines, Inc.
vial.
ANDA 064212................ Daunorubicin HCl for Do.
Injection USP, 20 mg
(base)/vial and 50
mg (base)/vial.
[[Page 43213]]
ANDA 065037................ Idarubicin HCl for Do.
Injection USP, 5 mg/
vial, 10 mg/vial,
and 20 mg/vial.
ANDA 065321................ Nystatin Topical Nesher
Powder USP, 100,000 Pharmaceuticals
units/gm. (USA) LLC.
ANDA 065433................ Mycophenolate Mofetil Zydus
Capsules, 250 mg. Pharmaceuticals
(USA) Inc., 73
Route 31 North,
Pennington, NJ
08534.
ANDA 065477................ Mycophenolate Mofetil Do.
Tablets, 500 mg.
ANDA 070159................ Tolazamide Tablets Par Pharmaceutical,
USP, 100 mg. Inc., One Ram Ridge
Rd., Spring Valley,
NY 10977.
ANDA 070160................ Tolazamide Tablets Do.
USP, 250 mg.
ANDA 070161................ Tolazamide Tablets Do.
USP, 500 mg.
ANDA 070431................ Valproic Acid Do.
Capsules, 250 mg.
ANDA 070577................ Verapamil HCl Hospira, Inc.
Injection USP, 2.5
mg/mL.
ANDA 070818................ Ibuprofen Tablets Ohm Laboratories, c/
USP, 400 mg. o Ranbaxy Inc., 600
College Rd. East,
Princeton, NJ
08540.
ANDA 070980................ Potassium Chloride Nesher
Extended-Release Pharmaceuticals
Capsules USP, 10 (USA) LLC.
milliequivalents.
ANDA 071200................ Disopyramide Do.
Phosphate Extended-
Release Capsules
USP, 150 mg.
ANDA 071726................ Metaproterenol Nephron
Sulfate Inhalation Pharmaceuticals
Solution, 0.6%. Corp., 4121 South
West 34th St.,
Orlando, FL 32811.
ANDA 071855................ Metaproterenol Do.
Sulfate Inhalation
Solution, 0.4%.
ANDA 072273................ Albuterol Inhalation Armstrong
Aerosol\1\. Pharmaceuticals,
Inc. 25 John Rd.,
Canton, MA 02021.
ANDA 072437................ Fenoprofen Calcium Par Pharmaceuticals,
Capsules USP, 200 mg. Inc.
ANDA 072974................ Methyldopate HCl Teva Parenteral
Injection USP. Medicines, Inc.
ANDA 073000................ Dopamine HCl Do.
Injection USP, 80 mg/
mL.
ANDA 073117................ Metoclopramine Hospira, Inc.
Injection USP, 5 mg/
mL.
ANDA 073465................ Sodium Nitroprusside Teva Parenteral
Injection, 25 mg/mL. Medicines, Inc.
ANDA 073617................ Pentamidine Baxter Healthcare
Isethionate for Corp.
Injection, 300 mg/
vial.
ANDA 073683................ Cyclobenzaprine HCl Sandoz Inc.
Tablets, 10 mg.
ANDA 074013................ Pindolol Tablets USP, Mylan
5 mg. Pharmaceuticals,
Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown,
WV 26505-4310.
ANDA 074018................ Pindolol Tablets USP, Do.
10 mg.
ANDA 074105................ Naproxen Tablets USP, DAVA
250 mg, 375 mg, and Pharmaceuticals,
500 mg. Inc., Parker Plaza,
400 Kelby St., 10th
Floor, Fort Lee, NJ
07024.
ANDA 074147................ Metoclopramide Hospira, Inc.
Injection USP, 5 mg/
mL.
ANDA 074206................ Dobutamine Injection Teva Parenteral
USP, 250 mg (base)/ Medicines, Inc.
20 mL.
ANDA 074252................ Cimetidine HCl Do.
Injection, EQ 300 mg
(base)/2 mL.
ANDA 074519................ Captopril Tablets, Sandoz Inc.
12.5 mg, 25 mg, 50
mg, and 100 mg.
ANDA 074613................ Bumetanide Injection Teva Parenteral
USP, 0.25 mg/mL. Medicines, Inc.
ANDA 074616................ Inamrinone Lactate Hospira, Inc.
Injection, 5 mg/mL.
ANDA 074629................ Iopamidol Injection Baxter Healthcare
USP, 41%, 51%, 61%, Corp.
and 76%.
ANDA 074637................ Iopamidol Injection Hospira, Inc.
USP, 61%.
ANDA 074753................ Atracurium Besylate Baxter Healthcare
Injection USP, 10 mg/ Corp.
mL (preserved).
ANDA 074768................ Atracurium Besylate Do.
Injection USP, 10 mg/
mL (preservative
free).
ANDA 074784................ Atracurium Besylate Teva Parenteral
Injection USP, 10 mg/ Medicines, Inc.
mL.
ANDA 074795................ Fluphenazine Do.
Decanoate Injection
USP, 25 mg/mL.
ANDA 074969................ Acyclovir for Do.
Injection USP, 500
mg/vial and 1,000 mg/
vial.
ANDA 075004................ Diltiazem HCl Hospira, Inc.
Injection, 5 mg/mL.
ANDA 075005................ Iopamidol Injection Do.
USP, 51%, 61%, and
76%.
ANDA 075012................ Etodolac Tablets USP, Mylan
400 mg and 500 mg. Pharmaceuticals,
Inc.
ANDA 075071................ Etodolac Capsules, Do.
200 mg and 300 mg.
ANDA 075119................ Buspirone HCl Tablet Egis Pharmaceuticals
USP, 5 mg, 10 mg, PLC, c/o GlobePharm
and 15 mg. Inc., 313 Pine St.,
Suite 204,
Deerfield, IL
60015.
NDA 075166................. Isosorbide SkyePharma AG, c/o
Mononitrate Extended- Compliance
Release Tablets, 60 Resources, LLC,
mg. 7100 Farmington
Lane, Hillsborough,
NC 27278.
ANDA 075328................ Pemoline Tablets, Vintage
18.75 mg, 37.5 mg, Pharmaceuticals,
and 75 mg. 120 Vintage Dr.,
Huntsville, AL
35811.
ANDA 075392................ Propofol Injectable Teva Parenteral
Emulsion, 10 mg/mL. Medicines, Inc.
------------------------------------------------------------------------
\1\ This product included an oral pressurized metered-dose inhaler that
contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
longer be used as a propellant for any albuterol metered-dose inhalers
(see 70 FR 17168, April 4, 2005).
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (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, approval of the applications listed in table 1 in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective August 19, 2013. 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 that
are in inventory on the date that this notice becomes effective (see
[[Page 43214]]
DATES) 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: July 15, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-17324 Filed 7-18-13; 8:45 am]
BILLING CODE 4160-01-P
