[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.

-----------------------------------------------------------------------

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requested that the approval of the applications be withdrawn.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.

 
------------------------------------------------------------------------
 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
------------------------------------------------------------------------

    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