[Federal Register Volume 71, Number 116 (Friday, June 16, 2006)]
[Notices]
[Pages 34940-34944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9440]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0222]
Merck & Co., Inc., et al.; Withdrawal of Approval of 65 New Drug
Applications and 52 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 65 new drug applications (NDAs) and 52 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be withdrawn.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 June 16, 2006.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table in this document have informed FDA that these drug products
are no longer marketed and have requested that FDA withdraw approval of
the applications. The applicants have also, by their requests, waived
their opportunity for a hearing.
------------------------------------------------------------------------
Application
No. Drug Applicant
------------------------------------------------------------------------
NDA 1-645 Vitamin B6 (pyridoxine Merck & Co., Inc., 770
hydrochloride (HCl)) Sumneytown Pike, P.O. Box 4,
BLA-20, West Point, PA 19486-
0004
------------------------------------------------------------------------
NDA 5-521 Heparin Sodium Injection Eli Lilly and Co., Lilly
USP Corporate Center,
Indianapolis, IN 46285
------------------------------------------------------------------------
NDA 5-657 Tubocurarine Chloride Bristol-Myers Squibb Co.,
Injection USP P.O. Box 4500, Princeton, NJ
08543-4500
------------------------------------------------------------------------
NDA 5-794 Sultrin Triple Sulfa Cream Ortho-McNeil Pharmaceutical,
and Triple Sulfa Tablets Inc., 1000 U.S. Highway 202,
P.O. Box 300, Raritan, NJ
08869-0602
------------------------------------------------------------------------
NDA 6-012 Folvron (folic acid and Lederle Laboratories, 401
iron) North Middleton Rd., Pearl
River, NY 10965
------------------------------------------------------------------------
NDA 7-149 Rubramin (cyanocobalamin) Bristol-Myers Squibb Co.
Tablets and Capsules
------------------------------------------------------------------------
NDA 7-504 Acthar (corticotropin for Aventis Pharmaceuticals,
injection) Inc., 200 Crossing Blvd., BX
2-309E, Bridgewater, NJ
08807
------------------------------------------------------------------------
NDA 7-794 Neothylline (dyphylline) Teva Pharmaceuticals USA,
1090 Horsham Rd., P.O. Box
1090, North Wales, PA 19454
------------------------------------------------------------------------
NDA 9-176 Cortril (hydrocortisone) Pfizer Global
Topical Ointment Pharmaceuticals, 235 East
42nd St., New York, NY 10017
------------------------------------------------------------------------
NDA 10-028 Equanil (meprobamate) Wyeth Pharmaceuticals, P.O.
Tablets Box 8299, Philadelphia, PA
19101-8299
------------------------------------------------------------------------
NDA 10-093 Biphetamine Celltech Pharmaceuticals,
(dextroamphetamine and Inc., 755 Jefferson Rd.,
amphetamine) Capsules P.O. Box 31710, Rochester,
NY 14603
------------------------------------------------------------------------
NDA 10-513 Ketonil (amino acids and Merck & Co., Inc.
electrolytes)
------------------------------------------------------------------------
NDA 10-787 Iron Dextran Injection Aventis Pharmaceuticals, Inc.
------------------------------------------------------------------------
NDA 10-799 Dimetane (brompheniramine Wyeth Consumer Healthcare, 5
maleate) Tablets and Giralda Farms, Madison, NJ
Extendtabs 07940
------------------------------------------------------------------------
NDA 11-340 Cerumenex (triethanolamine The Purdue Frederick Co., 1
polypeptide oleate- Stamford Forum, Stamford, CT
condensate), 10% 06901-3431
------------------------------------------------------------------------
[[Page 34941]]
NDA 11-960 Aristocort (triamcinolone Astellas Pharma US, Inc., 3
diacetate) Syrup Parkway North, Deerfield, IL
60015-2548
------------------------------------------------------------------------
NDA 11-984 Decadron Phosphate Merck & Co., Inc.
(dexamethasone sodium
phosphate) Sterile
Ophthalmic Solution
------------------------------------------------------------------------
NDA 12-122 Glucagon (glucagon HCl) Eli Lilly & Co.
for Injection
------------------------------------------------------------------------
NDA 12-281 Robaxisal (methocarbamol A.H. Robins Co., c/o Wyeth
USP and aspirin USP) Pharmaceuticals, P.O. Box
Tablets 8299, Philadelphia, PA 19101-
8299
------------------------------------------------------------------------
NDA 12-649 Periactin (cyproheptadine Merck & Co., Inc.
HCl)
------------------------------------------------------------------------
NDA 12-703 Elavil (amitriptyline HCl) AstraZeneca Pharmaceuticals,
Tablets 1800 Concord Pike, P.O. Box
8355, Wilmington, DE 19803-
8355
------------------------------------------------------------------------
NDA 12-704 Elavil (amitriptyline HCl) Do.
Injection
------------------------------------------------------------------------
NDA 13-220 Periactin (cyproheptadine Merck & Co., Inc.
HCl) Syrup, 2 milligrams
(mg)/5 milliliters (mL)
------------------------------------------------------------------------
NDA 13-400 Aldomet (methyldopa) Do.
Tablets
------------------------------------------------------------------------
NDA 13-401 Aldomet (methyldopate HCl) Do.
Injection, 50 mg/mL
------------------------------------------------------------------------
NDA 13-413 Dexacort Phosphate Celltech Pharmaceuticals,
(dexamethasone sodium Inc.
phosphate) in Respihaler
------------------------------------------------------------------------
NDA 16-016 Aldoclor-150 and -250 Merck & Co., Inc.
(methyldopa and
chlorothiazide) Tablets,
250 mg/150 mg and 250 mg/
250 mg
------------------------------------------------------------------------
NDA 16-030 Bayer 8 Hour Aspirin and Bayer Healthcare, LLC, 36
Measurin Aspirin (aspirin Columbia Rd., P.O. Box 1910,
extended-release Morristown, NJ 07962-1910
tablets), 650 mg
------------------------------------------------------------------------
NDA 16-099 Atromid-S (clofibrate) Wyeth Pharmaceuticals
Capsules
------------------------------------------------------------------------
NDA 16-745 Jergens Antibacterial Kao Brands Co., 2535 Springs
Deodorant (triclocarban, Grove Ave., Cincinnati, OH
1%) Soap 45214-1773
------------------------------------------------------------------------
NDA 16-888 Selsun Blue (selenium Abbott Laboratories, 625
sulfide) Cream/Shampoo, Cleveland Ave., Columbus, OH
1% 43215-1724
------------------------------------------------------------------------
NDA 17-569 Renoquid (sulfacytine) Glenwood LLC, 111 Cedar Lane,
Tablets Englewood, NJ 07631
------------------------------------------------------------------------
NDA 17-573 Vanceril (beclomethasone Schering Corp., 2000
dipropionate) Inhalation Galloping Hill Rd.,
Aerosol Kenilworth, NJ 07033
------------------------------------------------------------------------
NDA 17-659 Alupent (metaproterenol Boehringer Ingelheim
sulfate) Inhalation Pharmaceuticals, Inc., 900
Solution, 5% Ridgebury Rd., P.O. Box 368,
Ridgefield, CT 06877-0368
------------------------------------------------------------------------
NDA 17-781 Diprosone (betamethasone Schering Corp.
dipropionate) Lotion
------------------------------------------------------------------------
NDA 17-820 Dobutrex (dobutamine HCl) Eli Lilly & Co.
Sterile Injection
------------------------------------------------------------------------
ANDA 18-023 Lactated Ringer's B. Braun Medical, Inc., 2525
Injection USP McGaw Ave., P.O. Box 19791,
Irvine, CA 92623-9791
------------------------------------------------------------------------
ANDA 18-026 5% Dextrose and 0.9% Do.
Sodium Chloride (NaCl)
Injection
------------------------------------------------------------------------
ANDA 18-046 10% Dextrose Injection USP Do.
------------------------------------------------------------------------
ANDA 18-047 10% Dextrose and 0.9% NaCl Do.
Injection USP
------------------------------------------------------------------------
ANDA 18-184 0.45% NaCl Injection USP Do.
------------------------------------------------------------------------
ANDA 18-186 1/6 Molar Sodium Lactate Do.
Injection USP in Plastic
Container
------------------------------------------------------------------------
ANDA 18-197 Ibuprofen Tablets BASF Corp., 8800 Line Ave.,
Shreveport, LA 71106
------------------------------------------------------------------------
ANDA 18-252 Isolyte S (multi- B. Braun Medical, Inc.
electrolyte injection)
Injection
------------------------------------------------------------------------
ANDA 18-256 5% Dextrose in Ringer's Do.
Injection
------------------------------------------------------------------------
NDA 18-257 Tonocard (tocainide HCl) AstraZeneca Pharmaceuticals
Tablets, 400 mg and 600
mg
------------------------------------------------------------------------
[[Page 34942]]
ANDA 18-274 Isolyte S (multi- B. Braun Medical, Inc.
electrolyte injection)
with 5% Dextrose in
Plastic Container
------------------------------------------------------------------------
NDA 18-389 Aldomet (methyldopa) Oral Merck & Co., Inc.
Suspension, 250 mg/5 mL
------------------------------------------------------------------------
NDA 18-682 TZ-3 (1% tioconazole) Pfizer, Inc., 235 East 42nd
Dermal Cream St., New York, NY 10017
------------------------------------------------------------------------
NDA 18-686 Normodyne (labetalol HCl Schering Corp.
USP) Injection, 5 mg/mL
------------------------------------------------------------------------
NDA 18-687 Normodyne (labetalol HCl Do.
USP) Tablets
------------------------------------------------------------------------
ANDA 18-721 Ringer's Injection USP B. Braun Medical, Inc.
------------------------------------------------------------------------
NDA 18-754 Orudis (ketoprofen) Wyeth Pharmaceuticals
Capsules, 25 mg, 50 mg,
and 75 mg
------------------------------------------------------------------------
NDA 18-792 Neopham (amino acids) Hospira, Inc., 275 North
Injection Field Dr., Dept. 389, Bldg.
2, Lake Forest, IL 60045
------------------------------------------------------------------------
NDA 18-901 Aminess (essential amino Do.
acids injection with
histidine)
------------------------------------------------------------------------
NDA 18-911 Heparin Sodium in 5% Do.
Dextrose Injection and
Heparin Sodium in NaCl
Injection
------------------------------------------------------------------------
NDA 19-083 Theophylline and 5% B. Braun Medical, Inc.
Dextrose Injection
------------------------------------------------------------------------
NDA 19-107 Protropin (somatrem) for Genentech, Inc., 1 DNA Way
Injection MS242, South San
Francisco, CA 94080-4990
------------------------------------------------------------------------
ANDA 19-138 Alphatrex (betamethasone Savage Laboratories, 60
dipropionate cream USP) Baylis Rd., Melville, NY
0.05% 11747
------------------------------------------------------------------------
ANDA 19-143 Alphatrex (betamethasone Do.
dipropionate ointment
USP) 0.05%
------------------------------------------------------------------------
NDA 19-383 Proventil (albuterol Schering Corp.
sulfate extended-release
tablets USP) Repetabs
------------------------------------------------------------------------
NDA 19-401 Pseudo-12 Suspension Celltech Pharmaceuticals,
(pseudoephedrine Inc.
polistirex extended-
release suspension)
------------------------------------------------------------------------
NDA 19-523 Cysteine HCl Injection Hospira, Inc.
USP, 7.25%
------------------------------------------------------------------------
NDA 19-589 Vancenase AQ Schering Corp.
(beclomethasone
dipropionate) Nasal Spray
------------------------------------------------------------------------
NDA 19-621 Ventolin (albuterol GlaxoSmithKline
sulfate) Syrup Pharmaceuticals, 5 More Dr.,
P.O. Box 13358, Research
Triangle Park, NC 27709
------------------------------------------------------------------------
NDA 20-035 Ergamisol (levamisole HCl) Johnson & Johnson
Tablets Pharmaceutical Research and
Development, LLC, c/o
Janssen Pharmaceutical
Products, LP, 1125 Trenton-
Harbourton Rd., K1-02B,
Titusville, NJ 08560-0200
------------------------------------------------------------------------
NDA 20-176 VitaPed (multivitamins) Hospira, Inc.
------------------------------------------------------------------------
NDA 20-338 Differin (adapalene) Galderma Laboratories, LP,
Solution, 0.1% 14501 North Freeway, Fort
Worth, TX 76177
------------------------------------------------------------------------
NDA 20-759 Trovan (trovafloxacin Pfizer, Inc.
mesylate) Tablets, 100 mg
and 200 mg
------------------------------------------------------------------------
NDA 20-760 Trovan (alatrofloxacin Do.
mesylate) Injection
------------------------------------------------------------------------
NDA 20-847 Esclim (estradiol extended- Women First Healthcare, Inc.,
release film) Transdermal 380 Lexington Ave., New
System York, NY 10168
------------------------------------------------------------------------
NDA 20-962 Emla (2.5% lidocaine and AstraZeneca Pharmaceuticals
2.5% prilocaine)
Anesthetic Disc
------------------------------------------------------------------------
ANDA 40-023 Adrucil (fluorouracil Sicor Pharmaceuticals, Inc.,
injection USP), 50 mg/mL 19 Hughes, Irvine, CA 92618
------------------------------------------------------------------------
ANDA 40-147 Leucovorin Calcium Hospira, Inc.
Injection USP, 10 mg
(base)/mL
------------------------------------------------------------------------
NDA 50-039 Garamycin (gentamicin Schering Corp.
sulfate) Ophthalmic
Solution
------------------------------------------------------------------------
[[Page 34943]]
NDA 50-091 Chloroptic Allergan, Inc., 2525 Dupont
(chloramphenicol Dr., P.O. Box 19534, Irvine,
ophthalmic solution USP), CA 92623-9534
0.5%
------------------------------------------------------------------------
NDA 50-322 Neodecadron (neomycin Merck & Co., Inc.
sulfate and dexamethasone
sodium phosphate) Sterile
Ophthalmic Solution
------------------------------------------------------------------------
NDA 50-368 Ilotycin (erythromycin) Eli Lilly & Co.
Ophthalmic Ointment
------------------------------------------------------------------------
NDA 50-571 CefMax (cefmenoxime HCl) TAP Pharmaceutical Products,
Injection Inc., 675 North Field Dr.,
Lake Forest, IL 60045
------------------------------------------------------------------------
NDA 50-648 Clindamycin Phosphate Baxter Healthcare Corp.,
Injection in 5% Dextrose Route 120 & Wilson Rd.,
Round Lake, IL 60073
------------------------------------------------------------------------
ANDA 60-429 Sumycin Capsules Apothecon, c/o Bristol-Myers
(tetracycline HCl Squibb Co., P.O. Box 4500,
capsules USP) Princeton, NJ 08543-4500
------------------------------------------------------------------------
ANDA 62-480 Gentacidin Solution Novartis Pharmaceuticals
(gentamicin sulfate Corp., 1 Health Plaza, Bldg.
ophthalmic solution USP) 118, East Hanover, NJ 07936-
1080
------------------------------------------------------------------------
ANDA 62-597 Mytrex (nystatin and Savage Laboratories
triamcinolone acetonide
cream USP) 100,000 units/
gram (g) and 1 mg/g
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ANDA 62-601 Mytrex (nystatin and Do.
triamcinolone acetonide
ointment USP) 100,000
units/g and 1 mg/g
------------------------------------------------------------------------
ANDA 62-750 Pipracil (piperacillin for Wyeth Pharmaceuticals, Inc.
injection), 2 g, 3 g, and
4 g
------------------------------------------------------------------------
ANDA 63-186 Cephalexin Capsules USP, Apothecon, c/o Bristol-Myers
250 mg and 500 mg Squibb Co.
------------------------------------------------------------------------
ANDA 64-084 Sterile Bleomycin Sulfate Sicor Pharmaceuticals, Inc.
for Injection USP, 15 and
30 units/vial
------------------------------------------------------------------------
ANDA 70-083 Ibuprofen Tablets USP, 400 BASF Corp.
mg
------------------------------------------------------------------------
ANDA 70-099 Ibuprofen Tablets USP, 600 Do.
mg
------------------------------------------------------------------------
ANDA 70-273 Alphatrex (betamethasone Savage Laboratories
dipropionate lotion USP),
0.05%
------------------------------------------------------------------------
ANDA 70-745 Ibuprofen Tablets USP, 800 BASF Corp.
mg
------------------------------------------------------------------------
ANDA 72-621 Acetylcysteine Solution Roxane Laboratories, Inc.,
USP, 10% P.O. Box 16532, Columbus, OH
43216
------------------------------------------------------------------------
ANDA 72-622 Acetylcysteine Solution Do.
USP, 20%
------------------------------------------------------------------------
ANDA 72-995 Metoclopramide HCl Oral Do.
Solution, 10 mg/mL
------------------------------------------------------------------------
ANDA 73-562 Diflunisal Tablets USP, Do.
250 mg
------------------------------------------------------------------------
ANDA 73-563 Diflunisal Tablets USP, Do.
500 mg
------------------------------------------------------------------------
ANDA 74-166 Toposar (etoposide Sicor Pharmaceuticals, Inc.
injection USP), 20 mg/mL
------------------------------------------------------------------------
ANDA 74-541 Cimetidine HCl Oral Roxane Laboratories, Inc.
Solution, 30 mg/5 mL
------------------------------------------------------------------------
ANDA 74-663 Acyclovir Sodium for Hospira, Inc.
Injection USP, 500 mg
base/vial and 1 g base/
vial
------------------------------------------------------------------------
ANDA 75-179 Nabumetone Tablets Copley Pharmaceutical, Inc.,
1090 Horsham Rd., P.O. Box
1090, North Wales, PA 19454
------------------------------------------------------------------------
ANDA 75-875 Carbamazepine Oral Taro Pharmaceutical
Suspension USP, 100 mg/5 Industries, Ltd., c/o Taro
mL Pharmaceuticals, U.S. Agent,
5 Skyline Dr., Hawthorne, NY
10532
------------------------------------------------------------------------
ANDA 80-643 Diphenhydramine HCl Elixir Roxane Laboratories, Inc.
USP, 25 mg/10 mL
------------------------------------------------------------------------
ANDA 81-225 Adrucil (etopside Sicor Pharmaceuticals, Inc.
injection USP), 50 mg/mL
------------------------------------------------------------------------
ANDA 83-261 Pentobarbital Sodium Wyeth Pharmaceuticals
Injection USP
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ANDA 83-383 Diucardin Do.
(hydroflumethiazide
tablets USP) Tablets, 50
mg
------------------------------------------------------------------------
[[Page 34944]]
ANDA 84-015 Bleph-10 (sulfacetamide Allergan, Inc.
sodium ophthalmic
ointment USP) Ophthalmic
Ointment, 10%
------------------------------------------------------------------------
ANDA 84-514 Dilor (dyphylline tablets Savage Laboratories
USP), 200 mg
------------------------------------------------------------------------
ANDA 84-751 Dilor-400 (dyphylline Do.
tablets USP), 400 mg
------------------------------------------------------------------------
ANDA 85-035 Diphenoxylate HCl and R & S Pharma, LLC, 8407
Atropine Sulfate Tablets Austin Tracy Rd., Fountain
USP, 2.5 mg and 0.025 mg Run, KY 42133
------------------------------------------------------------------------
ANDA 85-961 Methocarbamol Tablets USP, Clonmel Healthcare Ltd., c/o
500 mg STADA Pharmaceuticals, Inc.,
U.S. Agent, 5 Cedar Brook
Dr., Cranbury, NJ 08512
------------------------------------------------------------------------
ANDA 85-963 Methocarbomal Tablets USP, Do.
750 mg
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ANDA 86-899 Isoetharine HCl Inhalation Roxane Laboratories, Inc.
Solution USP, 1%
------------------------------------------------------------------------
ANDA 87-450 Chlorthalidone Tablets Clonmel Healthcare Ltd.
USP, 50 mg
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ANDA 87-451 Chlorthalidone Tablets Do.
USP, 25 mg
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ANDA 87-500 Aminophylline Tablets USP, Roxane Laboratories, Inc.
100 mg
------------------------------------------------------------------------
ANDA 87-501 Aminophylline Tablets USP, Do.
200 mg
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ANDA 88-253 T-Phyl (theophylline) The Purdue Frederick Co.
Extended-Release Tablets,
200 mg
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Therefore, under section 505(e), of the Federal Food, Drug, and
Cosmetic 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 the table in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective June 16, 2006.
Dated: May 23, 2006.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E6-9440 Filed 6-15-06; 8:45 am]
BILLING CODE 4160-01-S