[Federal Register Volume 62, Number 122 (Wednesday, June 25, 1997)]
[Notices]
[Pages 34297-34300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16609]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 87N-0262]
Merck & Co., Inc., et al.; Withdrawal of Approval of 39 New Drug
Applications, 13 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 39 new drug applications (NDA's), 13 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that the approval of the applications be withdrawn.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: July 25, 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 had a hearing or have, by their
request, waived their opportunity for a hearing.
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Application No. Drug Applicant
------------------------------------------------------------------------
NDA 1-205....................... Propadrine Merck & Co., Inc.,
(Phenylephrine P.O. Box 4, BLA-
hydrochloride) 20, West Point,
Elixir. PA 19486.
NDA 5-151....................... Percorten Acetate Novartis, 556
(desoxy- Morris Ave.,
corticosterone Summit, NJ 07901-
acetate, USP 1395.
Pellets.
NDA 5-587....................... Phisoderm Cream... Sterling Drug,
Inc., 90 Park
Ave., New York,
NY 10016.
NDA 5-786....................... Ceepryn Merrell Dow
Concentrate Research
Solution. Institute, 2110
E. Galbraith Rd.,
Cincinnati, OH
45215-6300.
[[Page 34298]]
NDA 7-085....................... Cyanocobalamin Warner Chilcott,
Injection USP, Inc., Rockaway 80
1000 micrograms Corp. Center, 100
per milliliter Enterprise Dr.,
(mL). suite 280,
Rockaway, NJ
07866.
NDA 8-072....................... Peritrate Parke-Davis, 2800
(pentaerythritol Plymouth Rd., Ann
tetranitrate) Arbor, MI 48105.
Tablets, 10, 20,
and 40 milligrams
(mg).
NDA 8-279....................... Nalline Injection. Merck & Co., Inc.
NDA 8-319....................... Butazolidin Ciba Geigy Corp.,
Tablets and 556 Morris Ave.,
Capsules Summit, NY 07901-
(phenylbutazone 1398.
tablets and
capsules).
NDA 9-099....................... Bonine (meclizine Pfizer, Inc., 235
HCl)Chewable East 42d St., New
Tablets. York, NY 10017-
5755.
NDA 9-637....................... Hydrocortisone AC Akorn, Inc., P.O.
Injection(hydroco Box 1220,
rtisone acetate Decatur, IL
injection). 62525.
NDA 10-585...................... LERITINE Tablets.. Merck & Co., Inc.
NDA 11-109...................... Peritrate SA Parke-Davis.
Tablets, 80 mg.
NDA 11-983...................... Decadron Topical Merck & Co., Inc.
Cream.
NDA 12-108...................... Vaga Spray........ Menlo Park
Laboratories,
Inc., 459 Amboy
Ave., P.O. Box
648, Woodbridge,
NJ 07095.
NDA 12-311...................... Pentritol Rhone-Poulenc
(pentaerythritol Rorer
tetranitrate) Pharmaceuticals
Timed Release Inc., 500 Arcola
Tempules 60 mg. Rd., P.O. Box
1200,
Collegeville, PA
19426-0107.
NDA 12-487...................... Taractan Hoffmann-La Roche,
(chlorprothixene Inc., 340
Ampuls). Kingsland St.,
Nutley, NJ 07110-
1199.
NDA 16-219...................... Lemon Spree Colgate-Palmolive
Deodorant Soap. Co., 909 River
Rd., P.O. Box
1343, Piscataway,
NJ 08855-1343.
NDA 16-264...................... Palmolive Gold Do.
Antibacterial
Deodorant Soap.
NDA 16-278...................... Tackle Medicated Do.
Soap.
NDA 16-457...................... Pentritol Rhone-Poulenc
(pentaerythritol Rorer
tetranitrate) Pharmaceuticals
Timed Release Inc.
Tempules 30 mg.
NDA 16-486...................... P-300 Colgate-Palmolive
Antibacterial Co.
Deodorant Soap.
NDA 16-818...................... Emete-con Pfizer, Inc.
(benzquinmide
HCl)
Suppositories.
NDA 17-818...................... HALOG Westwood-Squibb
(halcinonide) Pharmaceuticals
Cream, 0.025%. Inc., 100 Forest
Ave., Buffalo, NY
114213-1091.
NDA 17-914...................... OTIC-TRIDESILON Bayer Corp., 400
(desonide-acetic Morgan Lane, West
acid) Solution, Haven, CT 06516-
0.05%. 4175
NDA 18-040...................... Monistat Janssen, 1125
(miconazole) i.v.. Trenton-
Harbourton Rd.,
P.O. Box 200,
Titusville, NJ
08560-0200.
NDA 18-793...................... Cold Capsule IV D. M. Graham
(phenyl- Laboratories,
propanolamine Inc., 58 Pearl
hydro-chloride 75 St., Hobart, NY
mg and 13788.
chlorpheniramine
maleate 12 mg
extended-release
capsules).
NDA 18-794...................... Cold Capsule V Do.
(phenylpropanolam
ine hydrochloride
75 mg and
chlorpheniramine
maleate 8 mg
extended-release
capsules).
NDA 18-843...................... Pseudoephrine Do.
hydrochloride 120
mg and
chlorpheniramine
maeleate 12 mg
extended-release
capsules.
NDA 18-844...................... Pseudoephredrine Do.
hydrochloride 120
mg and
chlorpheniramine
mealeate 8 mg
extended-release
capsules.
NDA 50-165...................... Polysporin Burroughs Wellcome
Ointment. Co., 3030
Cornwallis Rd.,
P.O. Box 12700,
Research Triangle
Park, NC 27709-
2700.
NDA 50-166...................... Polysporin Topical Do.
Powder.
NDA 50-170...................... Neosporin Ointment Do.
NDA 50-313...................... Fungizone Ointment Apothecon, P.O.
Box 4500,
Princeton, NJ
08543-4500.
NDA 50-323...................... NEODECADRON Merck &. Co., Inc.
Topical Cream.
NDA 50-325...................... NEODECASPRAY Do.
Topical Aerosol.
NDA 50-459...................... Amoxil SmitheKline
(amoxicillin Beecham, One
trihydrate) Franklin Plaza,
capsules. P.O. Box 7929,
Philadelphia, PA
19101.
NDA 50-460...................... Amoxicillin Do.
trihydrate for
oral suspension.
NDA 50-601...................... Ceradon (Cefotiam Takeda Chemical
HCl for Industries Ltd. c/
Injection). o Corning
Besselaar, Inc.,
210 Carnegie
Center,
Princeton, NJ
08540-6233.
NDA 50-678...................... DYNABAC Lilly Research
(dirithromycin Laboratories,
tablets). Lilly Corporate
Center,
Indianapolis, IN
46285.
AADA 60-095..................... Tetracycline Pfizer, Inc.
Suspension 100 mg/
mL and
Tetracycline
Suspension 125 mg/
5 mL.
AADA 60-199..................... Chloramphenicol Chong Kun Dang
Palmitate USP Corp., 14 Magnet
(nonsterile bulk). St., Stony Brook,
NY 11790.
AADA 60-200..................... Chloramphenicol Do.
USP, non-sterile
bulk.
AADA 60-285..................... Tetracycline Pfizer, Inc.
Hydrochloride
Intramuscular
Injection, 100 mg
and 250 mg vials
(both with
Procaine
Hydrochloride 2%).
AADA 60-436..................... Chloraphenicol Chong Kun Dang
Sodium Succinate Corp.
USP, (Sterile
bulk).
AADA 61-606..................... Pyocidin-Otic Forest
(Polymyxin B Laboratories,
Sulfate and Inc., 909 Third
Hydrocortisone Ave., New York,
Otic Solution NY 10022-4731.
USP); 10,000
units and 5 mg/
mL).
AADA 62-077..................... Ampicillin Sandoz
Anhydrous (bulk). Pharmaceutical,
Agent for Roferm
S.p.A., 59 Route
10, East Hanover,
NJ 07936-1080.
[[Page 34299]]
AADA 62-174..................... Erythromycin Pharmacia &
Ethylsuccinate, Upjohn, 7000
USP (nonsterile Portage Rd.,
bulk). Kalamzoo, MI
49001-0199.
AADA 62-301..................... Chloramphenacol Parke-Davis.
Palmitate
Suspension USP,
150 mg/5 mL.
AADA 62-647..................... Amoxicillin Sandoz
Trihydrate (bulk). Pharmaceuticals,
Agent for Roferm
S.p.A.
AADA 62-794..................... Clindamycin Biochimica Opos
Phosphate USP, S.p.A., c/o
nonsterile bulk. Kleinfeld,
Kaplan, and
Becker, 1140
Nineteenth St.
NW., suite
900,Washington,
DC 20036.
AADA 63-130..................... Minocycline Do.
Hydrochloride
(bulk,
nonsterile).
AADA 64-072..................... Cefaclor USP, Do.
(bulk,
nonsterile).
ANDA 70-516..................... Propranolol Roxane
Hydrochloride Laboratories,
Tablets USP, 10 Inc., P.O. Box
mg. 16532, Columbus,
OH 43216-6532.
ANDA 70-517..................... Propranolol Do.
Hydrochloride
Tablets USP, 20
mg.
ANDA 70-518..................... Propranolol Do.
Hydrochloride
Tablets USP, 40
mg.
ANDA 70-519..................... Propranolol Do.
Hydrochloride
Tablets USP, 60
mg.
ANDA 70-521..................... Propranolol Do.
Hydrochloride
Tablets USP, 90
mg.
ANDA 71-555..................... Nitropress Abbott
(Sterile Sodium Laboratories, D-
Nitroprusside, 389 Bldg., AP30,
USP) 50 mg vial. 200 Abbott Park
Rd., Abbott Park,
IL 60064-3537.
ANDA 80-368..................... Isoniazid Tablets Vintage
USP, 50 mg and Pharmaceuticals,
100 mg. Inc., 3241
Woodpark Blvd.,
Charlotte, NC
28206.
ANDA 80-778..................... Hydroxcobalamin Merck & Co., Inc.
Injection (Alpha
Redisol).
ANDA 83-089..................... Propoxyphene Roxane
Hydrochloride Laboratories,
Capsules USP, 65 Inc.
mg.
ANDA 84-772..................... Promethazine Alpharma, U.S.
Hydrochloride Pharmaceuticals
Syrup USP, 25 mg/ Division, 333
5 mL. Cassell Dr.,
suite 3500,
Baltimore, MD
21224.
ANDA 85-169..................... Theophylline Halsey Drug Col,
Elixir, 80 mg/15 Inc., 1827
mL. Pacific St.,
Brooklyn, NY
11233-3599.
ANDA 85-263..................... Theophylline KV Pharmaceutical
Capsules, 100 mg Co., 2503 South
and 200 mg. Hanely Rd., St.
Louis, MO 63144-
2555.
ANDA 85-364..................... Acetaminophen and Do.
Codeine Phosphate
Tablets, USP (300
mg/15 mg).
ANDA 85-365..................... Acetaminophen and Do.
Codeine Phosphate
Tablet, USP (300
mg/60 mg).
ANDA 85-523..................... Meclinzine Do.
Hydrochloride
Tablets USP, 25
mg.
ANDA 85-524..................... Meclizine Do.
Hydrochloride
Tablets USP, 12.5
mg.
ANDA 85-525..................... Phendimetrazine Do.
Tartrate Tablets
USP, 35 mg.
ANDA 85-555..................... Cyclopentolate Akorn
Hydrochloride Manufacturing,
Opthalmic Inc.
Solution USP, 1%.
ANDA 85-658..................... Methocarbamol KV Pharmaceutical
Tablets, USP (705 Co.
mg).
ANDA 85-659..................... Diphenoxylate Do.
Hydrochloride and
Atropine Sulfate
Tablets USP, 2.5
mg/0.25 mg.
ANDA 85-660..................... Methocarbamol Do.
Tablets, USP (500
mg).
ANDA 86-264..................... Ergoloid Mesylates Do.
Sublingual
Tablets (1.0 mg).
ANDA 86-265..................... Ergoloid Mesylates Do.
Sublingual
Tablets (0.5 mg).
ANDA 86-737..................... Cyproheptadine KV Pharmaceutical
Hydrochloride Co.
Tablets USP, 4 mg.
ANDA 86-760..................... Phyllocontin The Perdue
(Aminophylline Frederick Co.,
Controlled- 100 Connecticut
release Tablets), Ave., Norwalk, CT
225 mg. 06850-3590.
ANDA 87-164..................... Chlorpheniramine Do.
Maleate Tablets
USP, 4 mg.
ANDA 87-193..................... Theophylline D. M. Graham
Extended-release Laboratories,
Capsules, 250 mg. Inc.
ANDA 87-194..................... Theophylline Do.
Extended-release
Capsules, 100 mg.
ANDA 87-195..................... Diphenoxylate ICN
Hydrochloride Pharmaceuticals,
with Atropine Inc., ICN Plaza,
Sulfate Tablets, 3300 Hyland Ave,
2.5 mg/0.025 mg. Costa Mesa, CA
92626.
ANDA 87-243..................... Aminophyllin G. D. Searle and
Injection, USP. Co., 4901 Searle
Pkwy., Skokie, IL
60077.
ANDA 87-464..................... Oxycodone and Halsey Drug Co.,
Aspirin Tablets, Inc.
4.5 mg/235 mg.
ANDA 87-763..................... Theophylline D.M. Graham
Extended-release Laboratories,
Capsules, 50 mg. Inc.
ANDA 88-020..................... Trimcaps Do.
(Phendimetrazine
Tartrate Extended-
release Capsules,
105 mg).
ANDA 88-028..................... Dital Do.
(Phendimetrazine
Tartrate Extended-
release Capsules,
105 mg).
ANDA 88-063..................... Dyrexan-OD Do.
(Phendimetrazine
Tartrate Extended-
release Capsules,
105 mg).
ANDA 88-111..................... Rexigen Forte Do.
(Phendimetrazine
Tartrate Extended-
release Capsules,
105 mg).
ANDA 88-377..................... Propantheline Par
Bromide Tablets, Pharmaceutical,
15 mg. Inc., One Ram
Ridge Rd., Spring
Valley, NY 10977.
ANDA 88-382..................... Theophylline D. M. Graham
Extended-release Laboratories,
Capsules, 200 mg. Inc.
ANDA 88-383..................... Theophylline Do.
Extended-release
Capsules, 300 mg.
ANDA 88-577..................... Hydrocodone Barr Laboratories,
Bitartrate and Inc., Two Quaker
Acetaminophen Rd., P.O. Box
Tablets USP, 5 mg/ 2900, Pomona, NY
500 mg. 10970-0519.
ANDA 88-689..................... Theophylline Central
Extended release Pharmaceutical,
Capsules USP, 250 Inc., 120 East
mg. Third St.,
Seymour, IN 47274-
0328
ANDA 88-743..................... Endolor D. M. Graham
(Butalbital, Laboratories,
Acetaminophen, Inc.
and Caffeine
Capsules USP, 50
mg/325 mg/40 mg.
[[Page 34300]]
ANDA 88-765..................... Two-Dyne Do.
(Butalbital,
Acetaminophen,
and Caffeine
Capsules USP, 50
mg/325 mg/40 mg.
ANDA 89-067..................... Margesic Do.
(Butalbital,
Acetaminophen,
and Caffeine
Capsules USP, 50
mg/325 mg/40 mg.
ANDA 89-605..................... Prochlorperazine Steris
Edisylate Laboratories,
Injection USP, 5 Inc., 620 North
mg/mL. 51st Ave.,
Pheonix, AZ 85040-
4705.
ANDA 89-994..................... Oxycodone Halsey Drug Co.,
Hydrochloride and Inc.
Acetaminophen
Capulses, 5 mg/
500 mg.
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NDA's 8-072, 11-983, 12-311, and 16-457 were the subject of a
hearing (Docket No. 87N-0262 (52 FR 32170, August 26, 1987)). The
initial decision of the Administrative Law Judge (ALJ) was that the
drug products covered by the NDA's lacked substantial evidence of
effectiveness. The holder of NDA's 12-311 and 16-457 was stricken as a
party participant in the hearing for failure to file a notice of
participation, and the holder of NDA's 8-072 and 11-983 has formally
withdrawn its appeal of the initial decision of the ALJ. This notice,
therefore, constitutes final agency action on Docket No. 87N-0262
insofar as these four NDA's.
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)) approval of the applications listed in
the table in this document, and all amendments and supplements thereto,
is hereby withdrawn, effective July 25, 1997.
Dated: June 17, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-16609 Filed 6-24-97; 8:45 am]
BILLING CODE 4160-01-F
