[Federal Register Volume 75, Number 139 (Wednesday, July 21, 2010)]
[Notices]
[Pages 42455-42458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17785]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0318]
Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of
27 New Drug Applications and 58 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 27 new drug applications (NDAs) and 58 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be withdrawn.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: August 20, 2010.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 of this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications pursuant to 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.
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Application No. Drug Applicant
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NDA 6-008 Mesantoin (mephenytoin) Tablets Novartis Pharmaceuticals Corp., One Health
Plaza, East Hanover, NJ 07936-1080
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NDA 9-000 Cafergot (ergotamine tartrate and Do.
caffeine) Suppository, 1 milligram
(mg)/100 mg and 2 mg/100 mg
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NDA 9-561 Hypaque (diatrizoate sodium) GE Healthcare, Inc., 101 Carnegie Center,
Princeton, NJ 08540
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NDA 9-658 Hydrocortisone Tablets Smith, Miller and Patch, Inc., Division of
Cooper Vision, Inc., c/o Cooper Laboratories,
Inc., 455 E. Middlefied Rd., Mountain View,
CA 94043
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NDA 9-942 Deltra (prednisone) Tablets Merck & Co., Inc., P.O. Box 4, BLA-20, West
Point, PA 19486-0004
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NDA 10-051 Hydeltra (prednisolone) Tablets Do.
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NDA 10-255 Meticortelone (prednisolone acetate) Schering Corp., Galloping Hill Rd.,
Injection and Suspension Kenilworth, NJ 07033
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NDA 12-885 Winstrol (stanozolol) Tablets, 2 mg Lundbeck, Inc., Four Parkway North, Deerfield,
IL 60015
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NDA 13-428 Valpin (anisotropine methylbromide) Endo Pharmaceuticals, 100 Endo Blvd., Chadds
Tablets Ford, PA 19317
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[[Page 42456]]
NDA 16-023 Symmetrel (amantadine hydrochloride Do.
(HCl) USP) Syrup
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NDA 16-119 Teslac (testolactone) Injection, 100 Bristol-Myers Squibb Co., P.O. Box 4000,
mg/milliliter (mL) Princeton, NJ 08543-4000
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NDA 16-403 Hypaque-Cysto (diatrizoate meglumine) GE Healthcare, Inc.
and Hypaque (diatrizoate meglumine)
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NDA 16-636 Narcar (naloxone HCl) Injection Endo Pharmaceuticals
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NDA 16-769 Urispas (flavoxate HCl) Tablets, 100 Ortho-McNeil-Janssen Pharmaceutical, Inc.,
mg 1000 U.S. Highway 202, P.O. Box 3000,
Raritan, NJ 08869-0602
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NDA 17-022 Methotrexate Tablets Lederle Laboratories, A Division of American
Cyanamid Co., 401 N. Middletown Rd., Pearl
River, NY 10965
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NDA 17-118 Symmetrel (amantadine HCl USP) Syrup Endo Pharmaceuticals
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NDA 17-255 MPI DTPA Chelate multidose (kit for Medi-Physics, Inc., d/b/a GE Healthcare, Inc.,
the preparation of technetium Tc-99m 101 Carnegie Center, Princeton, NJ 08540
pentetate injection)
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NDA 17-264 Technetium Tc-99m pentetate kit Do.
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NDA 17-559 Proventil (albuterol USP) Inhalation Schering Corp.
Aerosol
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NDA 17-984 Valcaps (diazepam) Capsules Hoffmann-LaRoche, Inc., Roche Pharmaceuticals,
340 Kingsland St., Nutley, NJ 07110-1199
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NDA 18-101 Symmetrel (amantadine HCl USP) Tablets Endo Pharmaceuticals
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NDA 18-445 Dolobid (diflunisal) Tablets, 250 mg Merck & Co., Inc.
and 500 mg
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ANDA 18-551 Potassium Iodide Oral Solution USP, 1 Roxane Laboratories, Inc., 1809 Wilson Rd.,
gram (g)/mL Columbus, OH 43228
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NDA 18-706 Hydergine LC (ergoloid mesylates) Novartis Pharmaceuticals Corp.
Capsules
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NDA 18-746 Vasocon-A (antazoline phosphate, 0.5% Do.
and naphazoline HCl, 0.05%)
Ophthalmic Solution
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ANDA 18-750 Furosemide Tablets, 40 mg Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC
27893
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NDA 19-309 Vasotec (enalaprilat) Injection Biovail Laboratories International SRL, c/o
Biovail Technologies Ltd., 700 Route 202/206
North, Bridgewater, NJ 08807
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NDA 21-007 Agenerase (amprenavir), 50 mg and 150 GlaxoSmithKline, One Franklin Plaza, 200 North
mg 16th St., Philadelphia, PA 19102
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NDA 21-039 Agenerase (amprenavir) Oral Solution, Do.
15 mg/mL
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ANDA 40-149 Hydrocodone Bitartrate and Sandoz, Inc.
Acetaminophen Tablets USP, 5 mg/500
mg and 7.5 mg/750 mg
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ANDA 40-312 Innofem (estradiol tablets USP), 0.5 Novo Nordisk, Inc., 100 College Rd. West,
mg, 1 mg, and 2 mg Princeton, NJ 08540
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ANDA 60-568 Urobiotic (oxytetracycline HCl, Pfizer Inc., 235 East 42nd St., New York, NY
sulfamethizole, phenazopyridine HCl) 10017
Capsules
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ANDA 61-016 Terra-Cortril (hydrocortisone acetate Do.
and oxytetracycline HCl)
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ANDA 61-410 Veetids (penicillin V potassium for Apothecon, c/o Bristol-Myers Squibb, P.O. Box
Oral Solution USP), 125 mg/5 mL and 4000, Princeton, NJ 08543
250 mg/5 mL
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ANDA 61-471 Tetracycline HCl Capsules, 250 mg Sandoz, Inc.
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ANDA 61-781 Erythromycin StearateTablets, 250 mg Do.
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ANDA 61-965 Nystatin Vaginal Tablets, 100,000 Do.
Units
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ANDA 62-014 Oxytetracycline Capsules, 250 mg Do.
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ANDA 62-065 Nystatin Tablets, 500,000 Units Do.
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[[Page 42457]]
ANDA 62-590 Kefurox (cefuroxime for injection Eli Lilly & Co., Lilly Corporate Center,
USP), 750 mg/vial and 1.5 g/vial Indianapolis, IN 46285
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ANDA 62-592 Kefurox (cefuroxime for injection Do.
USP), 750 mg/vial and 1.5 g/vial
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ANDA 64-033 Cefazolin Sodium ADD-Vantage Powder GlaxoSmithKline, One Franklin Plaza, P.O. Box
for Injection Solution 7929, Philadelphia, PA 19101-7929
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ANDA 65-210 Clarithromycin Extended-Release Ranbaxy, Inc., U.S. Agent for Ranbaxy
Tablets, 1,000 mg Laboratories Limited, 600 College Rd. East,
Princeton, NJ 08540
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ANDA 73-696 Nitrofurantoin Capsules USP, 25 mg, 50 Watson Laboratories, Inc., P.O. Box 450 39 Mt.
mg, and 100 mg Ebo Rd. South, Brewster, NY 10509
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ANDA 74-648 Lorazepam Oral Solution, 0.5 mg/5 mL Roxane Laboratories, Inc.
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ANDA 74-764 Ranitidine Injection USP Bedford Laboratories, A division of Ben Venue
Laboratories, Inc., 300 Northfield Rd.,
Bedford, OH 44146
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ANDA 75-170 Butorphanlol Tartrate Injection USP, 1 Hospira, Inc., 275 N. Field Dr., Dept. 0389,
mg/mL and 2 mg/mL Bldg. H2, Lake Forest, IL 60045-5046
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ANDA 76-027 Tamoxifen Citrate Tablets USP, 10 mg Roxane Laboratories, Inc.
and 20 mg
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ANDA 76-605 Gabapentin Tablets USP, 600 mg and 800 Do.
mg
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ANDA 76-643 Carbidopa and Levodopa Tablets for Do.
Oral Suspension, 10 mg/100 mg, 25 mg/
100 mg, and 25 mg/250 mg
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ANDA 76-663 Carbidopa and Levodopa Extended- KV Pharmaceutical Co., 2503 South Hanley Rd.,
Release Tablets, 50 mg/200 mg St. Louis, MO 63144
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ANDA 77-366 Glimepiride Tablets USP, 3 mg and 6 mg Ranbaxy Inc.
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ANDA 81-096 Acetaminophen, Aspirin, and Codeine Mikart, Inc., 1750 Chattahoochee Ave., NW,
Phosphate Capsules, 150 mg/180 mg/30 Atlanta, GA 30318
mg
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ANDA 81-097 Acetaminophen, Aspirin, and Codeine Do.
Phosphate Capsules, 150 mg/180 mg/60
mg
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ANDA 81-226 Hydrocodone Bitartrate and Do.
Acetaminophen Oral Solution, 5 mg/500
mg/15 mL
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ANDA 83-902 Dexedrine (dextroamphetamine sulfate), GlaxoSmithKline, Research Triangle Park, NC
5 mg/mL 27709-3398
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ANDA 84-353 Bethanechol Chloride Tablets, 5 mg Do.
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ANDA 84-378 Bethanechol Chloride Tablets, 10 mg Do.
(Blue)
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ANDA 84-379 Bethanechol Chloride Tablets, 10 mg Do.
(Pink)
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ANDA 84-383 Bethanechol Chloride Tablets, 25 mg Do.
(Yellow)
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ANDA 84-384 Bethanechol Chloride Tablets, 25 mg Do.
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ANDA 84-617 Hydralazine HCl and Reserpine Tablets, Do.
25 mg/0.1 mg
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ANDA 84-773 Prednisolone Tablets, 5 mg Do.
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ANDA 84-774 Prednisone Tablets, 5 mg Do.
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ANDA 84-869 Imipramine HCl Tablets, 25 mg Do.
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ANDA 84-876 Hydrochlorothiazide, Reserpine, and Do.
Hydralazine HCl Tablets, 15 mg/0.1 mg/
25 mg
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ANDA 84-935 Dexedrine (dextroamphetamine sulfate) GlaxoSmithKline, Research Triangle Park, NC
Tablets 27709-3398
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ANDA 84-956 Hydralazine HCl Tablets, 25 mg Sandoz, Inc.
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[[Page 42458]]
ANDA 85-088 Hydralazine HCl Tablets, 50 mg Do.
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ANDA 85-146 Promethazine HCl Tablets, 25 mg and 50 Do.
mg
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ANDA 85-934 Butabarbital Sodium Tablets, 30 mg Do.
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ANDA 85-938 Butabarbital Sodium Tablets, 15 mg Do.
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ANDA 86-171 Trichlormethiazide Tablets, 4 mg Do.
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ANDA 86-505 Hypaque-76 (diatrizoate meglumine and GE Healthcare, Inc.
diatrizoate sodium injection USP)
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ANDA 87-118 Chlorthalidone Tablets, 50 mg Sadoz, Inc.
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ANDA 87-282 Methocarbamol Tablets, 750 mg Do.
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ANDA 87-283 Methocarbamol Tablets, 500 mg Do.
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ANDA 87-449 Theophylline Oral Solution, 80 mg/15 Roxane Laboratories, Inc.
mL
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ANDA 87-462 Theophylline Extended-Release Sandoz, Inc.
Capsules, 260 mg
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ANDA 88-157 Chlorpromazine HCl Intensol Roxane Laboratories, Inc.
(chlorpromazine HCl oral concentrate
USP), 30 mg/mL
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ANDA 88-158 Chlorpromazine HCl Intensol Do.
(chlorpromazine HCl oral concentrate
USP), 100 mg/mL
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ANDA 88-193 Triprolidine HCl and Pseudoephedrine Sandoz, Inc.
HCl Tablets, 2.5 mg/60 mg
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ANDA 88-587 Hydrochlorothiazide Oral Solution Roxane Laboratories, Inc.
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ANDA 89-127 Mepro-Aspirin (aspirin and Sandoz, Inc.
meprobamate) Tablets, 325 mg/200 mg
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ANDA 89-508 Fluorouracil Injection USP, 50 mg/mL Bedford Laboratories
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Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the 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 20, 2010. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the 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: June 15, 2010.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 2010-17785 Filed 7-20-10; 8:45 am]
BILLING CODE 4160-01-S