[Federal Register Volume 62, Number 152 (Thursday, August 7, 1997)]
[Notices]
[Pages 42575-42577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20871]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0326]
Sterling Drug, Inc., et al.; Withdrawal of Approval of 28 New
Drug Applications, 9 Abbreviated Antibiotic Applications, and 46
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 28 new drug applications (NDA's), 9 abbreviated antibiotic
applications (AADA's), and 46 abbreviated new drug applications
(ANDA's). 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that the approval of the applications be withdrawn.
EFFECTIVE DATE: September 8, 1997.
FOR FURTHER INFORMATION CONTACT: Olivia A. Vieira, 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 request, waived
their opportunity for a hearing.
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Application No. Drug Applicant
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NDA 6-801 Neocurtasal Sterling Drug, Inc., 90 Park Ave., New York,
NY 10016.
NDA 8-472 Cyclaine Merck & Co., Inc., P.O. Box 4, BLA-20, West
Point, PA 19486.
NDA 8-656 Hydrocortone Acetate Topical Ointment Do.
[[Page 42576]]
NDA 9-241 Serfia Tablets Westerfield Pharma, 3941 Brotherton Rd.,
Cincinnati, OH 45209.
NDA 9-272 Evraserp Tablets Evron Indust., 7475 North Rogers Ave.,
Chicago, IL 60626.
NDA 9-443 Rauwolfia Serpentina Tablets Direct Laboratories, 377 Genesse St.,
Buffalo, NY 14204.
NDA 9-459 Hexamethonium Chloride Tablets Global Pharms, 3725 Castor Ave.,
Philadelphia, PA 19124.
NDA 9-599 Sustac (Nitroglycerin) Extended-release Key Pharms, 909 Third Ave., New York, NY
Tablets, 2.6 milligrams (mg) and 6.5 mg 10022-4731.
NDA 9-720 Reserpine Tablets S. F. Durst & Co., Inc., 1683 Winchester Rd.,
Philadelphia, PA 19020.
NDA 9-765 Reserpine Tablets Hance Brothers & White Co., 12th & Hamilton
Sts., Philadelphia, PA 19123.
NDA 9-812 Reserpine Tablets Boyle & Co., 6330 Chalet Dr., Los Angeles, CA
90022.
NDA 9-926 Rauserpin Tablets Ferndale Laboratories, Inc., 780 West Eight
Mile Rd., Ferndale, MI 48220.
NDA 10-260 Ecolid Chloride Novartis Pharms, 556 Morris Ave., Summit, NJ
07901.
NDA 10-408 Ekans Tablets 100 mg Haag, Inc., 5 South 15th St., Richmond, VA
23219.
NDA 10-576 Perivas Tablets Grant Chemical Co., Inc., 924 Rogers Ave.,
Brooklyn, NY 11226.
NDA 10-581 Hyserpin Tablets Phys Products, 50 Washington St., Norwalk, CT
06856.
NDA 10-632 Serpena Tablets 0.25 mg (Reserpine) Haag, Inc.
NDA 10-751 Reserpine Tablets Horton & Converse Laboratories, Inc., 2200
South Figueroa St., Los Angeles, CA 90007.
NDA 10-883 Serpanray Injection Panray, P.O. Box 150, Englewood, NJ 07631.
NDA 12-128 Fovane (benzthiazide) Tablets Pfizer, 235 East 42d St., New York, NY 10017-
5755.
NDA 12-285 Syntocinon (oxytocin nasal solution) Nasal Novartis Pharmaceutical Corp., 59 Rte. 10,
Spray East Hanover, NJ 07936-1080.
NDA 12-911 Metopirone (metyrapone USP) Tablets (only Novartis Pharms.
those portions of NDA that deal with Tablets)
NDA 12-985 Duphaston (Dydrogesterone) Tablets, 5, 10, and Solvay Pharmaceuticals, 901 Sawyer Rd.,
20 mg Marietta, GA 30062.
NDA 13-412 CUEMID Merck & Co., Inc.
NDA 13-538 Decaderm Do.
NDA 17-926 Regular Insulin (insulin injection, USP Novo Nordisk Pharmaceuticals, Inc., Suite
(Pork)) 200, 100 Overlook Center, Princeton, NJ
08540-7810.
NDA 17-929 NPH Insulin (isophane insulin suspension, USP Do.
(Beef))
NDA 17-998 Lente Insulin (insulin zinc suspension, USP Do.
(Beef))
AADA 60-633 Tetracycline Syrup, 125 mg/5 milliliters (mL) Alpharma, U.S. Pharmaceuticals Div., Suite
3500, 3333 Cassell Dr., Baltimore, MD 21224.
AADA 60-730 Neomycin and Polymyxin B Sulfates and Steris Laboratories, Inc., 620 North 51st
Hydrocortisone Otic Solution, USP Ave., Phoenix, AZ 85043-4705.
AADA 61-450 Oxacillin Sodium Capsules, USP Apothecon, Inc., P.O. Box 4500, Princeton, NJ
08543-4500.
AADA 62-300 Tetracycline Hydrochloride Capsules USP, 250 Warner Chilcott, Inc., Rockaway 80 Corp.
mg and 500 mg Center, 100 Enterprise Dr., Suite 280,
Rockaway, NJ 07866.
AADA 62-521 Neomycin and Polymyxin B Sulfates and Steris Laboratories, Inc.
Hyrocortisone Otic Suspension, USP
AADA 62-625 Ampicillin Trihydrate Non-Sterile Bulk SmithKline Beecham Pharmaceuticals, 1250
South Collegeville Rd., P.O. Box 5089,
Collegeville, PA 19426-0989.
AADA 62-724 Cefadyl (Sterile Cephapirin Sodium, USP), ADD- Apothecon, Inc.
Vantage vials
AADA 62-973 Cephalexin Capsules USP, 250 mg Do.
AADA 62-974 Cephalexin Capsules USP, 500 mg Do.
ANDA 70-042 Metronidazole Injection USP, 5 mg/mL Steris Laboratories, Inc.
ANDA 70-452 Methyldopa Tablets, USP, 500 mg Purepac Pharmaceutical Co., 200 Elmora Ave.,
Elizabeth, NJ 07207.
ANDA 70-749 Methyldopa Tablets, USP, 125 mg Do.
ANDA 70-750 Methyldopa Tablets, USP, 250 mg Do.
ANDA 70-912 Diazepam Injection USP, 5 mg/mL Steris Laboratories, Inc.
ANDA 71-122 Ibuprofen Tablets, USP, (200 mg, orange) Purepac Pharmaceutical Co.
ANDA 71-455 Pseudoephedrine Hydrochloride and KV Pharmaceutical Co., 2503 South Hanley Rd.,
Chlorpheniramine Maleate Extended-Release St. Louis, MO 63144-2555.
Capsules, 120 mg/12 mg
ANDA 71-656 Metaproterenol Sulfate Syrup USP, (10 mg/5 mL) Morton Grove Pharmaceuticals, Inc., 6451 West
Main St., Morton Grove, IL 60053.
ANDA 71-664 Ibuprofen Tablets, USP, (200 mg, white) Purepac Pharmaceutical Co.
ANDA 71-964 Ibuprofen Tablets, USP, 800 mg Do.
ANDA 72-758 Triprolidine and Pseudoephedrine KV Pharmaceutical Co.
Hydrochlorides Extended-Release Caplets, 5 mg/
120 mg
ANDA 80-325 Prednisolone Tablets, 5 mg Purepac Pharmaceutical Co.
ANDA 80-753 Reserpine Tablets USP, 0.1 mg and 0.25 mg Do.
ANDA 83-013 Cyanocobalamin Injection USP, 100 micrograms Steris Laboratories, Inc.
(g)/mL
ANDA 83-064 Cyanocobalamin Injection USP, 1,000 g/ Do.
mL
ANDA 83-120 Cyanocobalamin Injection USP, 100 g/ Do.
mL and 1,000 g/mL
ANDA 83-532 Promethazine Hydrochloride Injection USP, 50 Do.
mg/mL
[[Page 42577]]
ANDA 83-533 Diphenhydramine Hydrochloride Injection USP, Do.
10 mg/mL
ANDA 83-534 Thiamine Hydrochloride Injection USP, 100 mg/ Do.
mL and 200 mg/mL
ANDA 83-535 Procaine Hydrochloride Injection USP, 1% and Do.
2%
ANDA 83-595 Testosterone Propionate Injection USP, 100 mg/ Do.
mL
ANDA 83-627 Lidocaine Hydrochloride Injection USP, 1% and Do.
2%
ANDA 83-654 Sterile Prednisolone Acetate Suspension USP, Do.
25 mg/mL
ANDA 83-667 Testosterone Enanthate Injection USP, 100 mg/ Do.
mL and 200 mg/mL
ANDA 83-759 Sterile Hydrocortisone Acetate Sterile Do.
Suspension USP, 25 mg/mL and 50 mg/mL
ANDA 83-760 Pyridoxine Hydrochloride Injection USP, 100 mg/ Do.
mL
ANDA 84-355 Dexamethasone Sodium Phosphate Injection USP, Do.
4 mg/mL (base)
ANDA 84-401 Testosterone Cypionate Injection USP, 100 mg/ Do.
mL and 200 mg/mL
ANDA 84-740 Phendimetrazine Tartrate Tablets, 35 mg (Gray) Inwood Laboratories, Inc., 909 Third Ave.,
New York, NY 10022-4731.
ANDA 84-741 Phendimetrazine Tartrate Tablets, 35 mg Do.
(Yellow)
ANDA 84-742 Phendimetrazine Tartrate Tablets, 35 mg (Pink) Do.
ANDA 84-743 Phendimetrazine Tartrate Tablets, 35 mg Do.
(Green)
ANDA 85-374 Sterile Methylprednisolone Acetate Sterile Steris Laboratories, Inc.
Suspension USP, 40 mg/mL
ANDA 85-463 Lidocaine Hydrochloride and Epinephrine Do.
Injection USP 1%; 0.01 mg/mL
ANDA 85-528 Hydroxocobalamin Injection USP, 1,000 g/mL
ANDA 85-529 Sterile Triamcinolone Diacetate Suspension Do.
USP, 40 mg/mL
ANDA 85-781 Sterile Prednisolone Acetate Suspension USP, Do.
50 mg/mL
ANDA 86-052 Hydrocortisone Acetate Cream, 1% Purepac Pharmaceutical Co.
ANDA 86-507 Sterile Methylprednisolone Acetate Suspension Steris Laboratories, Inc.
USP, 80 mg/mL
ANDA 87-192 Triamcinolone Acetonide Lotion USP, 1% Alpharma, U.S. Pharmaceuticals Div.
ANDA 87-214 Phendimetrazine (Extended-release Capsules, D. M. Graham Laboratories, Inc., 58 Pearl
105 mg) St., P.O. Box P, Hobart, NY 13788.
ANDA 87-248 Sterile Methylprednisolone Acetate Suspension Steris Laboratories, Inc.
USP, 20 mg/mL
ANDA 87-598 Nandrolone Decanoate Injection USP, 50 mg/mL Do.
ANDA 87-599 Nandrolone Decanoate Injection USP, 100 mg/mL Do.
ANDA 88-062 Hyrex-105 (Phendimetrazine Tartrate Extended- D. M. Graham Laboratories, Inc.
release Capsules, 105 mg)
ANDA 88-305 Axotal Tablets (Butalbital and Aspirin Tablets Savage Laboratories, 60 Baylis Rd., Melville,
USP) 50 mg/650 mg NY 11747.
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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 (21 CFR 5.82),
approval of the applications listed in the table in this document, and
all amendments and supplements thereto, is hereby withdrawn, effective
September 8, 1997.
Dated: July 17, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-20871 Filed 8-6-97; 8:45 am]
BILLING CODE 4160-01-F