[Federal Register Volume 64, Number 111 (Thursday, June 10, 1999)]
[Notices]
[Pages 31226-31228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14656]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-1590]
Merck & Co., Inc., et al.; Withdrawal of Approval of 32 New Drug
Applications and 48 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 32 new drug applications (NDA's) and 48 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requested that the approval of the applications be withdrawn.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 12, 1999.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, 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
------------------------------------------------------------------------
NDA 5-620 Mannitol Injection Merck & Co., Inc., P.O. Box
4, BLA-20, West Point, PA
19486.
NDA 6-903 Milibis (glycobiarsol) Sanofi Pharmaceuticals,
Tablets Inc., 90 Park Ave., New
York, NY 10016.
NDA 7-542 Tromexan Tablets Novartis Pharmaceuticals
Corp., 59 Route 10, East
Hanover, NJ 07936-1080.
NDA 8-153 Dramamine (dimenhydrinate) G.D. Searle & Co., 4901
Injection Searle Pkwy., Skokie, IL
60077.
NDA 8-843 Pro-Banthine (propantheline Do.
bromide) Injection
NDA 10-126 VapoSteam Richardson-Vicks, 1 Far
Mill Crossing, Shelton, CT
06484.
NDA 11-316 Temaril (trimeprazine Allergan, 2525 Dupont Dr.,
tartrate) Tablets, Syrup, P.O. Box 19534, Irvine, CA
and Capsules 92623-9534.
NDA 11-583 Hydeltrasol Injection Merck & Co., Inc.
NDA 12-575 Actifed with Codeine Glaxo Wellcome Inc. 5 Moore
(pseudoephedrine hydro- Dr., P.O. Box 13398,
chloride, 30 milligrams Research Triangle Park, NC
(mg)/5 milliliters (mL), 27709.
triprolidine hydrochloride,
25 mg/5 mL, codeine
phosphate, 10 mg/5 mL)
NDA 13-553 Esimil (guanethidine Novartis Pharmaceuticals
monosulfate/hydro- Corp.
chlorothiazide) Combination
Tablets
NDA 15-865 Levoprome Immunex Corp., 51
(methotrimeprazine) University St., Seattle,
Injection WA 98101-2936.
NDA 16-349 10% Dextrose Injection Baxter Healthcare Corp.,
Rte. 120 and Wilson Rd.,
Round Lake, IL 60073-0490.
NDA 16-717 10% Travert (invert sugar) Do.
Injection in PL 146
Container
NDA 16-938 Catarase (chymotrypsin Ciba Vision Ophthalmics,
intraocular solution) 11460 John Creek Pkwy.,
1:5000 Ophthalmic Duluth, GA 30097-1556.
Intraocular Solution
NDA 17-796 Byrel (piperazine citrate) Sanofi Pharmaceuticals,
Syrup Inc.
[[Page 31227]]
NDA 17-916 Stannous Macro-aggregated Syncor Pharmaceuticals,
Albumin (SnMAA) Inc., 1313 Washington
Ave., Golden, CO 80401.
NDA 17-954 Bretylol (bretylium Faulding Pharmaceutical
tosylate) Injection, 50 mg/ Co., 200 Elmora Ave.,
mL Elizabeth, NJ 07207.
NDA 18-115 Triaminic-12 (phenyl- Novartis Consumer Health,
propanolamine hydro- Inc., 560 Morris Ave.,
chloride 75 mg and Summit, NJ 07901-1312.
chlorpheniramine maleate 12
mg) Sustained-release
Tablets
NDA 18-193 Velosulin (Regular purified Novo Nordisk
pork insulin) Injection Pharmaceuticals Inc., 100
Overlook Ctr., suite 200,
Princeton, NJ 08540-7810.
NDA 18-194 Insulatard (NPH purified Do.
pork isophane insulin
suspension) Injection
NDA 18-195 Mixtard 70/30 (70% purified Do.
pork isophane suspension
and 30% purified pork
insulin) Injection
NDA 18-580 Yutopar (ritodrine Astra USA Inc., P.O. Box
hydrochloride) Injection 4500, Westborough, MA
01581-4500.
NDA 18-698 Thallous Chloride TL-201 Syncor Pharmaceuticals,
Injection Inc.
NDA 18935 Pseudoephedrine Schwarz Pharma, P.O. Box
Hydrochloride 120 mg/ 2038, Milwaukee, WI 53201.
Chlorpheniramine Maleate 12
mg Extended-release
Capsules
NDA 19-381 Ten-K Tablets (Potassium Novartis Pharmaceuticals
Chloride Extended-release Corp.
Tablets USP)
NDA 19-580 Osmovist (iotrolan) Berlex Laboratories, Inc.,
Injection 340 Changebridge Rd., P.O.
Box 1000, Montville, NJ
07450-1000.
NDA 19-585 Mixtard Human 70/30 (70% Novo Nordisk
human insulin isophane Pharmaceuticals Inc.
suspension and 30% human
insulin (semisynthetic))
Injection
NDA 20-755 Caverject (alprostadil Pharmacia & Upjohn, 7000
injection) aqueous, 5 Portage Rd., Kalamazoo, MI
microgram (mcg)/mL (only 49001-0199.
those portions of NDA that
deal with 5 mcg/mL
strength)
NDA 50-031 RONDOMYCIN (methacycline Pfizer Inc., 235 East 42d
hydrochloride) Syrup St., New York, NY 10017-
5755.
NDA 50-073 Coly-Mycin M Diagnostic Parke-Davis Pharmaceutical
(sodium colistimethate for Research, 2800 Plymouth
diagnostic use) Rd., Ann Arbor, MI 48105.
NDA 50-075 Polycillin (ampicillin Bristol-Myers Squibb Co.,
trihydrate) P.O. Box 4000, Princeton,
NJ 08543-4000.
NDA 50-287 TERRAMYCIN (oxytetra- Pfizer Inc.
cycline) Tablets
ANDA 40-097 Hydrocortisone and Acetic Bausch & Lomb
Acid Otic Solution USP, 1%/ Pharmaceuticals, Inc.,
2% 8500 Hidden River Pkwy.,
Tampa, FL 33637.
ANDA 63-163 Clindamycin Phosphate Bedford Laboratories, Div.
Injection USP, 150 mg/mL) of Ben Venue Laboratories,
Inc., 270 Northfield Rd.,
Bedford, OH 44146.
ANDA 70-107 PROPACET 100 (Propoxyphene Teva Pharmaceuticals USA,
Napsylate and Acetaminophen 1510 Delp Dr., Kulpsville,
Tablets USP), 100 mg/650 mg PA 19443.
ANDA 70-691 Methyldopate Hydrochloride Faulding Pharmaceutical
Injection USP, 50 mg/mL Co., 11 Commerce Dr.,
Cranford, NJ 07016.
ANDA 70-732 Propoxyphene Napsylate and Teva Pharmaceuticals USA
Acetaminophen Tablets USP, Do.
100 mg/650 mg
ANDA 70-849 Methyldopate Hydrochloride Faulding Pharmaceutical Co.
Injection USP, 50 mg/mL
ANDA 70-969 Thiothixene Hydrochloride Alpharma, U.S.
Oral Solution USP Pharmaceuticals Div., 333
(Concentrate) 5 mg/mL Cassell Dr., suite 3500,
Baltimore, MD 21224.
ANDA 71-990 Metoclopramide Injection Faulding Pharmaceutical Co.
USP, 5 mg/mL
ANDA 72-155 Metoclopramide Injection Bedford Laboratories.
USP, 5 mg/mL
ANDA 72-244 Metoclopramide Injection Do.
USP, 5 mg/mL
ANDA 72-247 Metoclopramide Injection Do.
USP, 5 mg/mL
ANDA 72-383 Sulfamethoxazole and Do.
Trimethoprim for Injection
Concentrate USP
ANDA 72-427 Potassium Chloride Extended- Savage Laboratories, 60
release Capsules USP, 10 Baylis Rd., Melville, NY
milliequivalents (mEq) 11747.
ANDA 72-966 Albuterol Sulfate Tablets Copley Pharmaceutical,
USP, 2 mg Inc., 25 John Rd., Canton,
MA 02021.
ANDA 72-967 Albuterol Sulfate Tablets Do.
USP, 4 mg
ANDA 73-307 Albuterol Sulfate Inhalation Do.
Solution, 0.5%
ANDA 73-398 Potassium Chloride Extended- Savage Laboratories Do.
release Capsules USP, 8 mEq
ANDA 73-495 Albuterol Sulfate Inhalation Copley Pharmaceutical, Inc.
Solution, 0.083%
ANDA 74-285 Diflunisal Tablets USP, 250 Purepac Pharmaceutical Co.,
mg and 500 mg 200 Elmora Ave.,
Elizabeth, NJ 07207.
ANDA 74-406 Sufentanil Citrate Injection Steris Laboratories, Inc.,
USP, 50 mcg/mL 620 North 51st Ave.,
Phoenix, AZ 85043-4705.
ANDA 74-665 Inapamide Tablets USP, 1.25 Novopharm N.C. Inc., U.S.
mg and 2.5 mg Agent for Novopharm Ltd.,
4700 Novopharm Blvd.,
Wilson, NC 27893.
ANDA 80-763 Hydramine (diphenhydramine Alpharma.
hydrochloride) Elixir 12.5
mg/5 mL
ANDA 83-296 Aeroseb-DEX (dexamethasone Allergan Herbert, P.O. Box
0.01%) Topical Aerosol 19534, Irvine, CA 92623-
Spray 9534.
ANDA 84-055 ELDECORT (Hydro-cortisone ICN Pharmaceuticals, Inc.,
Cream USP) 2.5% 3300 Hyland Ave., Costa
Mesa, CA 92626.
ANDA 85-482 LIBRITABS (Chlordiazepoxide Do.
Tablets USP)
[[Page 31228]]
ANDA 85-805 Aeroseb-HC (hydrocortisone Allergan Herbert.
0.5%) Topical Aerosol Spray
ANDA 86-164 Nitrol Ointment Savage Laboratories.
(Nitroglycerin Ointment,
2%)
ANDA 86-604 Sustachron (Nitroglycerin Forest Laboratories, Inc.,
Extended-release) Buccal 909 Third Ave., New York,
Tablets, 5 mg NY 10022-4731.
ANDA 87-171 Sustachron (Nitroglycerin Do.
Extended-release) Buccal
Tablets, 2.5 mg
ANDA 87-286 Sustachron (Nitroglycerin Do.
Extended-release) Buccal
Tablets, 1 mg
ANDA 87-322 Sustachron (Nitroglycerin Do.
Extended-release) Buccal
Tablets, 1.5 mg
Sustachron (Nitroglycerin Do.
Extended-release) Buccal
Tablets, 2 mg
ANDA 87-615 Sustachron (Nitroglycerin Do.
Extended-release) Buccal
Tablets, 3 mg
ANDA 87-782 Nitrol Ointment Savage Laboratories.
(Nitroglycerin Ointment, 2%
unit-dose)
ANDA 87-998 Spironolactone Tablets USP, Purepac Pharmaceutical Co.
25 mg
ANDA 88-421 Amitriptyline Hydro-chloride Copley Pharmaceutical Inc.
Tablets USP, 10 mg
ANDA 88-422 Amitriptyline Hydro-chloride Do.
Tablets USP, 25 mg
ANDA 88-423 Amitriptyline Hydro-chloride Do.
Tablets USP, 50 mg
ANDA 88-424 Amitriptyline Hydro-chloride Do.
Tablets USP, 75 mg
ANDA 88-425 Amitriptyline Hydro-chloride Do.
Tablets USP, 100 mg
ANDA 88-426 Amitriptyline Hydro-chloride Do.
Tablets USP, 150 mg
ANDA 89-817 DEY-LUTE (Isoetharine Dey, L.P., 2751 Napa Valley
Inhalation Solution USP) Corporate Dr., Napa, CA
Sulfite-Free, 0.08% 94558.
ANDA 89-818 DEY-LUTE (Isoetharine Do.
Inhalation Solution USP)
Sulfite-Free, 0.1%
ANDA 89-819 DEY-LUTE (Isoetharine Do.
Inhalation Solution USP)
Sulfite-Free, 0.17%
ANDA 89-820 DEY-LUTE (Isoetharine Do.
Inhalation Solution USP)
Sulfite-Free, 0.25%
ANDA 89-932 Theophylline Extended- F.H. Faulding & Co., Ltd.,
Release Capsules, 300 mg U.S. Agent: Faulding Inc.,
200 Elmora Ave.,
Elizabeth, NJ 07207.
ANDA 89-976 Theophylline Extended- Do.
Release Capsules, 100 mg
ANDA 89-977 Theophylline Extended- Do.
Release Capsules, 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 (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
July 12, 1999.
Dated: May 24, 1999.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 99-14656 Filed 6-9-99; 8:45 am]
BILLING CODE 4160-01-F
