Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated New Drug Applications, 16039-16042 [2012-6591]
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Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices
ACTION:
Notice.
emcdonald on DSK29S0YB1PROD with NOTICES
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Circulatory
System Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 25 and 26, 2012, from 8
a.m. to 6 p.m.
Location: Holiday Inn, Ballroom, 2
Montgomery Village Ave., Gaithersburg,
MD 20879. The hotel’s phone number is
301–948–8900.
Contact Person: Jamie Waterhouse,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–3063,
email: Jamie.Waterhouse@fda.hhs.gov,
or FDA Advisory Committee
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modifications before coming to the
meeting.
Agenda
On April 25, 2012, the committee will
discuss, make recommendations and
vote on information related to a
supplement to the premarket approval
application (PMA) for the HeartWare
Ventricular Assist System (HVAS)
sponsored by HeartWare, Inc. The
HVAS is an implantable electrically
powered centrifugal-flow rotary blood
pump with external driver and power
source(s). It is the first ventricular assist
device that does not require the creation
of an abdominal pump pocket. The
HVAS is indicated for use as a bridge to
cardiac transplantation in patients who
are at risk of death from refractory,
advanced heart failure.
On April 26, 2012, the committee will
discuss, make recommendations and
vote on information related to the PMA
for the Subcutaneous Implantable
Cardioverter Defibrillator (S–ICD)
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System sponsored by Cameron Health,
Inc. The S–ICD is the first implantable
defibrillator that does not require the
implantation of an electrode either on or
in the heart. The S–ICD is intended to
provide defibrillation therapy for the
treatment of life-threatening ventricular
tachyarrhythmias. The device is capable
of delivering high energy defibrillation
shocks as well as bradycardia demand
mode cardiac pacing. The study
provides data from the treatment of
induced acute and chronic episodes of
ventricular tachycardia/ventricular
fibrillation and spontaneous episodes.
In addition to the investigational device
exemption study, clinical data were also
obtained from using studies outside the
United States and registries.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure
Interested persons may present data,
information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
April 17, 2012. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. on
April 25 and 26, 2012. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before April 10, 2012. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 12, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
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16039
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
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the meeting.
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AboutAdvisoryCommittees/
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 13, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–6484 Filed 3–16–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0190]
Abbott Laboratories et al.; Withdrawal
of Approval of 35 New Drug
Applications and 64 Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 35 new drug applications
(NDAs) and 64 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: April 18, 2012.
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 in this document have informed
SUMMARY:
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Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices
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.
TABLE 1
Application No.
Drug
Applicant
NDA 005545 ........................
Dicumarol Tablets ...........................................................
NDA 005845 ........................
NDA 010021 ........................
Benadryl (diphenhydramine hydrochloride (HCl)),
Benadryl with Ephedrine Sulfate, and Caladryl
(diphenhydramine HCl and calamine).
Benadryl (diphenhydramine HCl)) Injection ....................
Artane (trihexyphenidyl HCl) Tablets and Capsules and
Artane (trihexyphenidyl) Elixir.
Benadryl (diphenhydramine HCl)) Injection Preservative
Free.
Placidyl (ethchlorvynol) Capsules ...................................
Abbott Laboratories, PA77/Bldg. AP30–1E, 200 Abbott
Park Rd., Abbott Park, IL 60064–6157.
McNeil Consumer Healthcare, Division of McNeil-PPC,
Inc., 7050 Camp Hill Rd., Fort Washington, PA
19034–2299.
Do.
Lederle Laboratories, d/b/a Wyeth Pharmaceuticals,
P.O. Box 8299, Philadelphia, PA 19101–8299.
McNeil Consumer Healthcare.
NDA 011552 ........................
Stelazine (trifluoperazine HCl) ........................................
NDA 012524 ........................
NDA 014684 ........................
Enduron (methyclothiazide) Tablets, 2.5 milligrams (mg)
and 5 mg.
Enduronyl and Enduronyl Forte (methyclothiazide and
deserpidine) Tablets.
Aventyl (nortriptyline HCl) Capsules ...............................
NDA 017577 ........................
Ditropan (oxybutynin chloride) Tablets ...........................
NDA 018473 ........................
NDA 018557 ........................
NDA 018709 ........................
Ventolin (albuterol) Inhalation Aerosol1 ..........................
Fansidar (sulfadoxine and pyrimethamine) Tablets, 500
mg and 25 mg.
Capozide (captopril and hydrochlorothiazide) Tablets ...
NDA 018814 ........................
Heparin Sodium in 5% Dextrose Injection ......................
NDA 019297 ........................
Novantrone (mitoxantrone HCl) Injection ........................
NDA 019508 ........................
Axid (nizatidine) Capsules ..............................................
NDA 019915 ........................
NDA 019960 ........................
NDA 020057 ........................
Monopril (fosinopril sodium) Tablets, 10 mg, 20 mg,
and 40 mg.
Nuromax (doxacurium chloride) Injection 1 mg/milliliter
(mL).
Manoplax (flosequinan) Tablets ......................................
Ceredase (alglucerase) Injection ....................................
NDA 020088 ........................
Norplant System (levonorgestrel) Implants .....................
NDA 020101 ........................
NDA 020236 ........................
NDA 020286 ........................
NDA 020403 ........................
Prozac (fluoxetine HCl) Oral Solution, 20 mg/5 mL .......
Serevent (salmeterol xinafoate) Inhalation Aerosol1 ......
Monopril-HCT
(fosinopril
sodium
and
hydrochlorothiazide) Tablets, 20 mg/12.5 mg and 10
mg/12.5 mg.
Zofran (ondansetron HCl) Injection .................................
NDA 020627 ........................
NDA 020828 ........................
NDA 020860 ........................
Norplant II System (levonorgestrel) Implants .................
Fortovase (saquinavir) Capsules, 200 mg ......................
Levlite (ethinyl estradiol and levonorgestrel) Tablets .....
NDA 020984 ........................
Raplon (rapacuronium bromide) for Injection .................
NDA 021120 ........................
NDA 021793 ........................
Novantrone (mitoxantrone HCl) Injection ........................
Reglan ODT (metoclopramide) Tablets ..........................
ANDA 040207 ......................
ANDA 040231 ......................
Prochlorperazine Maleate Tablets USP, 5 mg and 10
mg.
Chlorpromazine HCl Oral Concentrate USP, 30 mg/mL
NDA 050526 ........................
Staticin (erythromycin) Topical Solution, 1.5% ...............
NDA 006146 ........................
NDA 006773 ........................
NDA 009486 ........................
NDA 012775 ........................
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NDA 019946 ........................
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Abbott Laboratories, 200 Abbott Park Rd., Abbott Park,
IL 60064.
GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709–3398.
Abbott Laboratories, PA77/Bldg. AP30–1E, 200 Abbott
Park Rd., Abbott Park, IL 60064–6157.
Do.
Eli Lilly and Co., Lilly Corp. Center, Indianapolis, IN
46285.
Janssen Pharmaceuticals Inc., c/o Johnson & Johnson
Pharmaceutical Research and Development, LLC,
920 Route 202, P.O. Box 300, Raritan, NJ 08869.
GlaxoSmithKline.
Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ
07110–1199.
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543–4000.
Baxter Healthcare Corp., 1620 Waukegan Rd., MPGR–
AL, McGaw Park, IL 60085.
EMD Serono, One Technology Place, Rockland, MA
02370.
SmithKline Beecham Corp., d/b/a GlaxoSmithKline,
P.O. Box 13398, Five Moore Dr., Research Triangle
Park, NC 27709–3398.
Bristol-Myers Squibb Co.
Abbott Laboratories, P76/Bldg. AP30–1E, Abbott Park,
IL 60064–6157.
Do.
Genzyme Corp., 500 Kendall St., Cambridge, MA
02142.
Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101–8299.
Eli Lilly and Co.
GlaxoSmithKline.
Bristol-Myers Squibb Co.
Glaxo Wellcome Manufacturing Pte Limited, d/b/a
GlaxoSmithKline, 1250 Collegeville Rd., UP4110,
Collegeville, PA 19426.
Wyeth Pharmaceuticals, Inc.
Hoffman-La Roche, Inc.
Bayer HealthCare Pharmaceuticals Inc., P.O. Box
1000, Montville, NJ 07045.
Organon USA Inc., 2000 Galloping Hill Rd., Kenilworth,
NJ 07033.
EMD Serono.
Meda Pharmaceuticals Inc., 200 North Cobb Parkway,
Suite 428, Marietta, GA 30062.
Duramed Pharmaceuticals, Inc., 400 Chestnut Rd.,
Woodcliff Lake, NJ 07677.
Pharmaceutical Associates, Inc., 201 Delaware St.,
Greenville, SC 29605.
Bristol-Myers Squibb Co.
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16041
TABLE 1—Continued
Application No.
Drug
Applicant
NDA 050687 ........................
Banan (cefpodoxime proxetil) Tablets, 100 mg and 200
mg.
Banan (cefpodoxime proxetil) Granules for Oral Suspension, 50 mg/5 mL and 100 mg/5 mL.
Amikacin Sulfate Injection USP, 250 mg (base)/mL ......
Daiichi Sankyo, Inc., 399 Thornall St., 11th Floor, Edison, NJ 08837.
Do.
NDA 050688 ........................
ANDA 064098 ......................
ANDA
ANDA
ANDA
ANDA
064106
070505
070506
070566
......................
......................
......................
......................
ANDA 071015 ......................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
071554
073058
073479
074636
074898
075065
075176
......................
......................
......................
......................
......................
......................
......................
ANDA 075409 ......................
ANDA 075884 ......................
ANDA 076306 ......................
ANDA 077138 ......................
ANDA 077223 ......................
ANDA 077784 ......................
ANDA 078241 ......................
Mitomycin for Injection USP, 20 mg Vial ........................
Metoclopramide Injection USP, 5 mg/mL .......................
Metoclopramide Injection USP, 5 mg/mL .......................
Nitropress (sodium nitroprusside for Injection USP), 50
mg.
Haloperidol Oral Solution USP, 2 mg/mL .......................
Thiothixene HCl Oral Solution USP, 5 mg/mL ...............
Fluphenazine HCl Oral Solution USP, 5 mg/mL ............
Pentamidine Isethionate for Injection, 300 mg Vial ........
Iopamidol Injection USP, 41%, 51%, 61%, 76% ............
Iopamidol Injection USP, 41%, 51%, 61%, 76% ............
Acyclovir Sodium for Injection .........................................
Haloperidol Decanoate Injection, 50 mg/mL and 100
mg/mL.
Midazolam HCl Injection, 1 mg (base)/mL and 5 mg
(base)/mL.
Milrinone Lactate Injection, 1 mg/mL ..............................
Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200
mg.
Ciprofloxacin Injection USP in 5% Dextrose Injection ....
Terbinafine HCl Tablets, 250 mg (base) ........................
Risperidone Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3
mg, and 4 mg.
ANDA 081126 ......................
ANDA 081298 ......................
Sumatriptan Succinate Tablets, 25 mg, 50 mg, and 100
mg (base).
Sumatriptan Injection, 4 mg (base)/0.5 mL and 6 mg
(base)/0.5 mL.
Prednisolone Sodium Phosphate Oral Solution, 5 mg
(base)/5 mL.
Venlafaxine HCl Tablets, 25 mg (base), 37.5 mg
(base), 50 mg (base), 75 mg (base), and 100 mg
(base).
Succinylcholine Chloride Injection USP, 20 mg/mL .......
Dexamethasone Sodium Phosphate Injection USP, 4
mg/mL.
Dexamethasone Sodium Phosphate Injection USP .......
Chlorzoxazone Tablets, 250 mg .....................................
ANDA 081299 ......................
ANDA 081310 ......................
ANDA 087005 ......................
Chlorzoxazone Tablets, 500 mg .....................................
Fluphenazine HCl Elixir USP, 2.5 mg/5 mL ...................
Trichlormethiazide Tablets, 4 mg ....................................
ANDA 087007 ......................
ANDA 087032 ......................
Trichlormethiazide Tablets, 2 mg ....................................
Chlorpromazine HCl Oral Concentrate USP, 30 mg/mL
ANDA 087053 ......................
ANDA 088143 ......................
Chlorpromazine HCl Oral Concentrate USP, 100 mg/
mL.
Oxycodone and Acetaminophen Tablets USP, 5 mg/
325 mg.
Potassium Chloride for Injection Concentrate USP, 2
mEq/mL.
Trifluoperazine Oral Solution USP, 10 mg/mL ...............
ANDA 088194 ......................
Thioridazine HCl Tablets USP, 50 mg ............................
ANDA 088227 ......................
ANDA 088270 ......................
Thioridazine HCl Oral Solution USP (Concentrate), 100
mg/mL.
Thioridazine HCl Oral Solution USP (Concentrate), 30
mg/mL.
Thioridazine HCl Tablets USP, 10 mg ............................
ANDA 088271 ......................
Thioridazine HCl Tablets USP, 15 mg ............................
ANDA 078318 ......................
ANDA 078416 ......................
ANDA 078517 ......................
ANDA 080997 ......................
ANDA 081125 ......................
ANDA 087406 ......................
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ANDA 087585 ......................
ANDA 088258 ......................
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Hospira, Inc., 275 North Field Dr., Bldg. H2–2, Lake
Forest, IL 60045.
Do.
Do.
Do.
Do.
Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O.
Box 1090, North Wales, PA 19454.
Do.
Do.
Hospira, Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus,
OH 43228.
Teva Pharmaceuticals USA.
Roxane Laboratories, Inc.
Ratiopharm Inc., c/o Columbia Pharma Consulting
Services Inc., 490 Northwest Datewood Dr., Suite
400, Issaquah, WA 98027.
Roxane Laboratories, Inc.
TEVA Parenteral Medicines, Inc., 19 Hughes, Irvine,
CA 92618.
Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville,
AL 35811.
PLIVA Hrvatska d.o.o., c/o Barr Laboratories, Inc., 400
Chestnut Ridge Rd., Woodcliff Lake, NJ 07677
Organon USA Inc.
TEVA Parenteral Medicines, Inc., 19 Hughes, Irvine,
CA 92618.
Do.
Ranbaxy Inc., U.S. Agent for Ohm, 600 College Rd.
East, Princeton, NJ 08540.
Do.
Teva Pharmaceuticals USA.
Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring
Valley, NY 10977.
Do.
Morton Grove Pharmaceuticals, Inc., U.S. Agent for
Wockhardt EU Operations (Swiss) AG, 6451 West
Main St., Morton Grove, IL 60053.
Do.
Barr Laboratories, Inc., 400 Chestnut Ridge Rd.,
Woodcliff Lake, NJ 07677.
Luitpold Pharmaceuticals, Inc., One Luitpold Dr., P.O.
Box 9001, Shirley, NY 11967.
Morton Grove Pharmaceuticals, Inc., U.S. Agent for
Wockhardt EU Operations (Swiss) AG.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff
Lake, NJ 07677.
Morton Grove Pharmaceuticals, Inc., U.S. Agent for
Wockhardt EU Operations (Swiss) AG.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.
Do.
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Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices
TABLE 1—Continued
Application No.
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
088272
088273
088456
088493
088850
088907
......................
......................
......................
......................
......................
......................
ANDA
ANDA
ANDA
ANDA
ANDA
088933
088934
089135
089136
089173
......................
......................
......................
......................
......................
ANDA 089174 ......................
ANDA
ANDA
ANDA
ANDA
089207
089208
089209
089457
......................
......................
......................
......................
ANDA 089602 ......................
ANDA 089603 ......................
ANDA 089624 ......................
ANDA 089657 ......................
ANDA 089708 ......................
Drug
Applicant
Thioridazine HCl Tablets USP, 25 mg ............................
Thioridazine HCl Tablets USP, 100 mg ..........................
Thioridazine HCl Tablets USP, 100 mg ..........................
Thioridazine HCl Tablets USP, 10 mg ............................
Hydroflumethiazide Tablets USP, 50 mg ........................
Reserpine and Hydroflumethiazide Tablets, 0.125 mg/
50 mg.
Sulfinpyrazone Tablets, 100 mg .....................................
Sulfinpyrazone Capsules USP, 200 mg .........................
Methyclothiazide Tablets, 2.5 mg ...................................
Methyclothiazide Tablets, 5 mg ......................................
A–MethaPred (methylprednisolone sodium succinate for
injection USP), 500 mg (base)/Vial.
A–MethaPred (methylprednisolone sodium succinate for
injection USP), 1 gram (base)/Vial.
Methylprednisolone Tablets USP, 16 mg .......................
Methylprednisolone Tablets USP, 24 mg .......................
Methylprednisolone Tablets USP, 32 mg .......................
Perphenazine Tablets USP, 16 mg ................................
Thioridazine HCl Oral Solution USP, 30 mg/mL ............
Thioridazine HCl Oral Solution USP, 100 mg/mL ..........
Reversol (edrophonium chloride injection USP), 10 mg/
mL).
Methocarbamol and Aspirin Tablets, 400 mg/325 mg ....
Perphenazine Tablets USP, 4 mg ..................................
Do.
Do.
Teva Pharmaceuticals USA.
Do.
Par Pharmaceutical, Inc.
Do.
Do.
Do.
Do.
Do.
Hospira, Inc.
Do.
Par Pharmaceutical, Inc.
Do.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.
Teva Pharmaceuticals USA.
Do.
Organon USA Inc.
Par Pharmaceutical, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA.
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 or salmeterol metered-dose inhalers (see 70 FR 17168, April 4, 2005; 71 FR 70870, December
7, 2006).
emcdonald on DSK29S0YB1PROD with NOTICES
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 April 18,
2012. 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 in 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: February 16, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2012–6591 Filed 3–16–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
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clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Enrollment and ReCertification of Entities in the 340B
Drug Pricing Program (OMB No. 0915–
0327)—Revision
Section 602 of Public Law 102–585,
the Veterans Health Care Act of 1992,
enacted section 340B of the Public
Health Service Act (PHS Act)
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities.’’ Section
340B provides that a manufacturer who
sells covered outpatient drugs to eligible
entities must sign a pharmaceutical
pricing agreement with the Secretary of
Health and Human Services in which
the manufacturer agrees to charge a
price for covered outpatient drugs that
will not exceed an amount determined
under a statutory formula.
Covered entities which choose to
participate in the section 340B Drug
Pricing Program must comply with the
requirements of section 340B(a)(5) of the
PHS Act. Section 340B(a)(5)(A)
prohibits a covered entity from
accepting a discount for a drug that
would also generate a Medicaid rebate.
E:\FR\FM\19MRN1.SGM
19MRN1
]]>Agencies
[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Notices]
[Pages 16039-16042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6591]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0190]
Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug
Applications and 64 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 35 new drug applications (NDAs) and 64 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: April 18, 2012.
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 in this document have informed
[[Page 16040]]
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 005545.................. Dicumarol Tablets... Abbott Laboratories,
PA77/Bldg. AP30-1E,
200 Abbott Park
Rd., Abbott Park,
IL 60064-6157.
NDA 005845.................. Benadryl McNeil Consumer
(diphenhydramine Healthcare,
hydrochloride Division of McNeil-
(HCl)), Benadryl PPC, Inc., 7050
with Ephedrine Camp Hill Rd., Fort
Sulfate, and Washington, PA
Caladryl 19034-2299.
(diphenhydramine
HCl and calamine).
NDA 006146.................. Benadryl Do.
(diphenhydramine
HCl)) Injection.
NDA 006773.................. Artane Lederle
(trihexyphenidyl Laboratories, d/b/a
HCl) Tablets and Wyeth
Capsules and Artane Pharmaceuticals,
(trihexyphenidyl) P.O. Box 8299,
Elixir. Philadelphia, PA
19101-8299.
NDA 009486.................. Benadryl McNeil Consumer
(diphenhydramine Healthcare.
HCl)) Injection
Preservative Free.
NDA 010021.................. Placidyl Abbott Laboratories,
(ethchlorvynol) 200 Abbott Park
Capsules. Rd., Abbott Park,
IL 60064.
NDA 011552.................. Stelazine GlaxoSmithKline,
(trifluoperazine P.O. Box 13398,
HCl). Five Moore Dr.,
Research Triangle
Park, NC 27709-
3398.
NDA 012524.................. Enduron Abbott Laboratories,
(methyclothiazide) PA77/Bldg. AP30-1E,
Tablets, 2.5 200 Abbott Park
milligrams (mg) and Rd., Abbott Park,
5 mg. IL 60064-6157.
NDA 012775.................. Enduronyl and Do.
Enduronyl Forte
(methyclothiazide
and deserpidine)
Tablets.
NDA 014684.................. Aventyl Eli Lilly and Co.,
(nortriptyline HCl) Lilly Corp. Center,
Capsules. Indianapolis, IN
46285.
NDA 017577.................. Ditropan (oxybutynin Janssen
chloride) Tablets. Pharmaceuticals
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research and
Development, LLC,
920 Route 202, P.O.
Box 300, Raritan,
NJ 08869.
NDA 018473.................. Ventolin (albuterol) GlaxoSmithKline.
Inhalation
Aerosol\1\.
NDA 018557.................. Fansidar Hoffman-La Roche,
(sulfadoxine and Inc., 340 Kingsland
pyrimethamine) St., Nutley, NJ
Tablets, 500 mg and 07110-1199.
25 mg.
NDA 018709.................. Capozide (captopril Bristol-Myers Squibb
and Co., P.O. Box 4000,
hydrochlorothiazide Princeton, NJ 08543-
) Tablets. 4000.
NDA 018814.................. Heparin Sodium in 5% Baxter Healthcare
Dextrose Injection. Corp., 1620
Waukegan Rd., MPGR-
AL, McGaw Park, IL
60085.
NDA 019297.................. Novantrone EMD Serono, One
(mitoxantrone HCl) Technology Place,
Injection. Rockland, MA 02370.
NDA 019508.................. Axid (nizatidine) SmithKline Beecham
Capsules. Corp., d/b/a
GlaxoSmithKline,
P.O. Box 13398,
Five Moore Dr.,
Research Triangle
Park, NC 27709-
3398.
NDA 019915.................. Monopril (fosinopril Bristol-Myers Squibb
sodium) Tablets, 10 Co.
mg, 20 mg, and 40
mg.
NDA 019946.................. Nuromax (doxacurium Abbott Laboratories,
chloride) Injection P76/Bldg. AP30-1E,
1 mg/milliliter Abbott Park, IL
(mL). 60064-6157.
NDA 019960.................. Manoplax Do.
(flosequinan)
Tablets.
NDA 020057.................. Ceredase Genzyme Corp., 500
(alglucerase) Kendall St.,
Injection. Cambridge, MA
02142.
NDA 020088.................. Norplant System Wyeth
(levonorgestrel) Pharmaceuticals,
Implants. Inc., P.O. Box
8299, Philadelphia,
PA 19101-8299.
NDA 020101.................. Prozac (fluoxetine Eli Lilly and Co.
HCl) Oral Solution,
20 mg/5 mL.
NDA 020236.................. Serevent (salmeterol GlaxoSmithKline.
xinafoate)
Inhalation
Aerosol\1\.
NDA 020286.................. Monopril-HCT Bristol-Myers Squibb
(fosinopril sodium Co.
and
hydrochlorothiazide
) Tablets, 20 mg/
12.5 mg and 10 mg/
12.5 mg.
NDA 020403.................. Zofran (ondansetron Glaxo Wellcome
HCl) Injection. Manufacturing Pte
Limited, d/b/a
GlaxoSmithKline,
1250 Collegeville
Rd., UP4110,
Collegeville, PA
19426.
NDA 020627.................. Norplant II System Wyeth
(levonorgestrel) Pharmaceuticals,
Implants. Inc.
NDA 020828.................. Fortovase Hoffman-La Roche,
(saquinavir) Inc.
Capsules, 200 mg.
NDA 020860.................. Levlite (ethinyl Bayer HealthCare
estradiol and Pharmaceuticals
levonorgestrel) Inc., P.O. Box
Tablets. 1000, Montville, NJ
07045.
NDA 020984.................. Raplon (rapacuronium Organon USA Inc.,
bromide) for 2000 Galloping Hill
Injection. Rd., Kenilworth, NJ
07033.
NDA 021120.................. Novantrone EMD Serono.
(mitoxantrone HCl)
Injection.
NDA 021793.................. Reglan ODT Meda Pharmaceuticals
(metoclopramide) Inc., 200 North
Tablets. Cobb Parkway, Suite
428, Marietta, GA
30062.
ANDA 040207................. Prochlorperazine Duramed
Maleate Tablets Pharmaceuticals,
USP, 5 mg and 10 mg. Inc., 400 Chestnut
Rd., Woodcliff
Lake, NJ 07677.
ANDA 040231................. Chlorpromazine HCl Pharmaceutical
Oral Concentrate Associates, Inc.,
USP, 30 mg/mL. 201 Delaware St.,
Greenville, SC
29605.
NDA 050526.................. Staticin Bristol-Myers Squibb
(erythromycin) Co.
Topical Solution,
1.5%.
[[Page 16041]]
NDA 050687.................. Banan (cefpodoxime Daiichi Sankyo,
proxetil) Tablets, Inc., 399 Thornall
100 mg and 200 mg. St., 11th Floor,
Edison, NJ 08837.
NDA 050688.................. Banan (cefpodoxime Do.
proxetil) Granules
for Oral
Suspension, 50 mg/5
mL and 100 mg/5 mL.
ANDA 064098................. Amikacin Sulfate Hospira, Inc., 275
Injection USP, 250 North Field Dr.,
mg (base)/mL. Bldg. H2-2, Lake
Forest, IL 60045.
ANDA 064106................. Mitomycin for Do.
Injection USP, 20
mg Vial.
ANDA 070505................. Metoclopramide Do.
Injection USP, 5 mg/
mL.
ANDA 070506................. Metoclopramide Do.
Injection USP, 5 mg/
mL.
ANDA 070566................. Nitropress (sodium Do.
nitroprusside for
Injection USP), 50
mg.
ANDA 071015................. Haloperidol Oral Teva Pharmaceuticals
Solution USP, 2 mg/ USA, 1090 Horsham
mL. Rd., P.O. Box 1090,
North Wales, PA
19454.
ANDA 071554................. Thiothixene HCl Oral Do.
Solution USP, 5 mg/
mL.
ANDA 073058................. Fluphenazine HCl Do.
Oral Solution USP,
5 mg/mL.
ANDA 073479................. Pentamidine Hospira, Inc.
Isethionate for
Injection, 300 mg
Vial.
ANDA 074636................. Iopamidol Injection Do.
USP, 41%, 51%, 61%,
76%.
ANDA 074898................. Iopamidol Injection Do.
USP, 41%, 51%, 61%,
76%.
ANDA 075065................. Acyclovir Sodium for Do.
Injection.
ANDA 075176................. Haloperidol Do.
Decanoate
Injection, 50 mg/mL
and 100 mg/mL.
ANDA 075409................. Midazolam HCl Do.
Injection, 1 mg
(base)/mL and 5 mg
(base)/mL.
ANDA 075884................. Milrinone Lactate Do.
Injection, 1 mg/mL.
ANDA 076306................. Topiramate Tablets, Roxane Laboratories,
25 mg, 50 mg, 100 Inc., 1809 Wilson
mg, and 200 mg. Rd., Columbus, OH
43228.
ANDA 077138................. Ciprofloxacin Teva Pharmaceuticals
Injection USP in 5% USA.
Dextrose Injection.
ANDA 077223................. Terbinafine HCl Roxane Laboratories,
Tablets, 250 mg Inc.
(base).
ANDA 077784................. Risperidone Tablets, Ratiopharm Inc., c/o
0.25 mg, 0.5 mg, 1 Columbia Pharma
mg, 2 mg, 3 mg, and Consulting Services
4 mg. Inc., 490 Northwest
Datewood Dr., Suite
400, Issaquah, WA
98027.
ANDA 078241................. Sumatriptan Roxane Laboratories,
Succinate Tablets, Inc.
25 mg, 50 mg, and
100 mg (base).
ANDA 078318................. Sumatriptan TEVA Parenteral
Injection, 4 mg Medicines, Inc., 19
(base)/0.5 mL and 6 Hughes, Irvine, CA
mg (base)/0.5 mL. 92618.
ANDA 078416................. Prednisolone Sodium Vintage
Phosphate Oral Pharmaceuticals,
Solution, 5 mg 120 Vintage Dr.,
(base)/5 mL. Huntsville, AL
35811.
ANDA 078517................. Venlafaxine HCl PLIVA Hrvatska
Tablets, 25 mg d.o.o., c/o Barr
(base), 37.5 mg Laboratories, Inc.,
(base), 50 mg 400 Chestnut Ridge
(base), 75 mg Rd., Woodcliff
(base), and 100 mg Lake, NJ 07677
(base).
ANDA 080997................. Succinylcholine Organon USA Inc.
Chloride Injection
USP, 20 mg/mL.
ANDA 081125................. Dexamethasone Sodium TEVA Parenteral
Phosphate Injection Medicines, Inc., 19
USP, 4 mg/mL. Hughes, Irvine, CA
92618.
ANDA 081126................. Dexamethasone Sodium Do.
Phosphate Injection
USP.
ANDA 081298................. Chlorzoxazone Ranbaxy Inc., U.S.
Tablets, 250 mg. Agent for Ohm, 600
College Rd. East,
Princeton, NJ
08540.
ANDA 081299................. Chlorzoxazone Do.
Tablets, 500 mg.
ANDA 081310................. Fluphenazine HCl Teva Pharmaceuticals
Elixir USP, 2.5 mg/ USA.
5 mL.
ANDA 087005................. Trichlormethiazide Par Pharmaceutical,
Tablets, 4 mg. Inc., One Ram Ridge
Rd., Spring Valley,
NY 10977.
ANDA 087007................. Trichlormethiazide Do.
Tablets, 2 mg.
ANDA 087032................. Chlorpromazine HCl Morton Grove
Oral Concentrate Pharmaceuticals,
USP, 30 mg/mL. Inc., U.S. Agent
for Wockhardt EU
Operations (Swiss)
AG, 6451 West Main
St., Morton Grove,
IL 60053.
ANDA 087053................. Chlorpromazine HCl Do.
Oral Concentrate
USP, 100 mg/mL.
ANDA 087406................. Oxycodone and Barr Laboratories,
Acetaminophen Inc., 400 Chestnut
Tablets USP, 5 mg/ Ridge Rd.,
325 mg. Woodcliff Lake, NJ
07677.
ANDA 087585................. Potassium Chloride Luitpold
for Injection Pharmaceuticals,
Concentrate USP, 2 Inc., One Luitpold
mEq/mL. Dr., P.O. Box 9001,
Shirley, NY 11967.
ANDA 088143................. Trifluoperazine Oral Morton Grove
Solution USP, 10 mg/ Pharmaceuticals,
mL. Inc., U.S. Agent
for Wockhardt EU
Operations (Swiss)
AG.
ANDA 088194................. Thioridazine HCl Ivax
Tablets USP, 50 mg. Pharmaceuticals,
Inc., Subsidiary of
Teva
Pharmaceuticals
USA, 400 Chestnut
Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 088227................. Thioridazine HCl Morton Grove
Oral Solution USP Pharmaceuticals,
(Concentrate), 100 Inc., U.S. Agent
mg/mL. for Wockhardt EU
Operations (Swiss)
AG.
ANDA 088258................. Thioridazine HCl Do.
Oral Solution USP
(Concentrate), 30
mg/mL.
ANDA 088270................. Thioridazine HCl Ivax
Tablets USP, 10 mg. Pharmaceuticals,
Inc., Subsidiary of
Teva
Pharmaceuticals
USA.
ANDA 088271................. Thioridazine HCl Do.
Tablets USP, 15 mg.
[[Page 16042]]
ANDA 088272................. Thioridazine HCl Do.
Tablets USP, 25 mg.
ANDA 088273................. Thioridazine HCl Do.
Tablets USP, 100 mg.
ANDA 088456................. Thioridazine HCl Teva Pharmaceuticals
Tablets USP, 100 mg. USA.
ANDA 088493................. Thioridazine HCl Do.
Tablets USP, 10 mg.
ANDA 088850................. Hydroflumethiazide Par Pharmaceutical,
Tablets USP, 50 mg. Inc.
ANDA 088907................. Reserpine and Do.
Hydroflumethiazide
Tablets, 0.125 mg/
50 mg.
ANDA 088933................. Sulfinpyrazone Do.
Tablets, 100 mg.
ANDA 088934................. Sulfinpyrazone Do.
Capsules USP, 200
mg.
ANDA 089135................. Methyclothiazide Do.
Tablets, 2.5 mg.
ANDA 089136................. Methyclothiazide Do.
Tablets, 5 mg.
ANDA 089173................. A-MethaPred Hospira, Inc.
(methylprednisolone
sodium succinate
for injection USP),
500 mg (base)/Vial.
ANDA 089174................. A-MethaPred Do.
(methylprednisolone
sodium succinate
for injection USP),
1 gram (base)/Vial.
ANDA 089207................. Methylprednisolone Par Pharmaceutical,
Tablets USP, 16 mg. Inc.
ANDA 089208................. Methylprednisolone Do.
Tablets USP, 24 mg.
ANDA 089209................. Methylprednisolone Do.
Tablets USP, 32 mg.
ANDA 089457................. Perphenazine Tablets Ivax
USP, 16 mg. Pharmaceuticals,
Inc., Subsidiary of
Teva
Pharmaceuticals
USA.
ANDA 089602................. Thioridazine HCl Teva Pharmaceuticals
Oral Solution USP, USA.
30 mg/mL.
ANDA 089603................. Thioridazine HCl Do.
Oral Solution USP,
100 mg/mL.
ANDA 089624................. Reversol Organon USA Inc.
(edrophonium
chloride injection
USP), 10 mg/mL).
ANDA 089657................. Methocarbamol and Par Pharmaceutical,
Aspirin Tablets, Inc.
400 mg/325 mg.
ANDA 089708................. Perphenazine Tablets Ivax
USP, 4 mg. Pharmaceuticals,
Inc., Subsidiary of
Teva
Pharmaceuticals
USA.
------------------------------------------------------------------------
\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 or salmeterol metered-
dose inhalers (see 70 FR 17168, April 4, 2005; 71 FR 70870, December
7, 2006).
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 April 18, 2012. 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 in
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: February 16, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2012-6591 Filed 3-16-12; 8:45 am]
BILLING CODE 4160-01-P
