[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that the approval of the applications be withdrawn.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.

                                                                                                                
----------------------------------------------------------------------------------------------------------------
 Application No.                        Drug                                         Applicant                  
----------------------------------------------------------------------------------------------------------------
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.                    
                    (<greek-m>g)/mL                                                                             
ANDA 83-064        Cyanocobalamin Injection USP, 1,000 <greek-m>g/ Do.                                          
                    mL                                                                                          
ANDA 83-120        Cyanocobalamin Injection USP, 100 <greek-m>g/   Do.                                          
                    mL and 1,000 <greek-m>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 <greek-   Do.                                          
                    m>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.                                   
----------------------------------------------------------------------------------------------------------------

    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