[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Notices]
[Pages 26191-26193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0285]


Sanofi Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 
21 New Drug Applications and 62 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 21 new drug applications (NDA's) and 62 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requested that the approval of the applications be withdrawn.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: June 11, 1998.

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 4-496                  Pipanol Powder and Tablets (trihyphenidyl)  Sanofi Pharmaceuticals, Inc., 90 Park    
                                                                        Ave., New York, NY 10016.               
NDA 6-328                  Isuprel (isoproterenol hydrochloride)       Do.                                      
                            Sublingual Tablets, 10 milligrams (mg)                                              
                            and 15 mg                                                                           
NDA 7-514                  Insulin, NPH Iletin                         Eli Lilly and Co., Lilly Corporate       
                                                                        Center, Indianapolis, IN 46285.         
NDA 8-256                  Insulin                                     Do.                                      
NDA 8-717                  Acetaminophen Tablets USP (acetaminophen    Roxane Laboratories, Inc., P.O. Box      
                            tablets)                                    16532, Columbus, OH 43216-6532.         
NDA 8-847                  Sucostrin (succinylcholine chloride         Apothecon, Inc., P.O. Box 4500,          
                            injection)                                  Princeton, NJ 08543-4500.               
NDA 8-983                  Arfonad (trimethaphan camsylate) Ampules    Hoffmann-La Roche, Inc., 40 Kingsland    
                                                                        St., Nutley, NJ 07110-1199.             
NDA 9-088                  Neothylline (dyphylline) injection          TEVA Pharmaceuticals USA (formerly Lemmon
                                                                        Co.), 650 Cathill Rd., Sellersvile, PA  
                                                                        18960.                                  
NDA 9-300                  Insulin, Lente Iletin I                     Eli Lilly and Co.                        
NDA 9-410                  Lotusate Tablets and and Capsules           Sanofi Pharmaceuticals, Inc.             
                            (talbutal)                                                                          
NDA 9-479                  Jayne's Liquid Vermifuge (piperazine        Do.                                      
                            hexahydrate)                                                                        

[[Page 26192]]

                                                                                                                
NDA 10-966                 Insulin, Ultralente                         Eli Lilly and Co.                        
NDA 10-967                 Insulin, Semilente                          Do.                                      
NDA 11-446                 Sterane (prednisolone acetate injection)    Pfizer, Inc., 235 East 42d St., New York,
                            Intramuscular and Intra-Articular           NY 10017-5755.                          
NDA 11-724                 Fenarol Tablets (chlormezanone)             Sanofi Pharmaceuticals, Inc.             
NDA 17-108                 Methadone HydrochlorideTablets, 2.5 mg, 5   Eon Labs Manufacturing, Inc., 227-15     
                            mg, 10 mg, and 40 mg                        North Conduit Ave., Laurelton, NY 11413.
NDA 17-446                 pHisoScrub (hexachlorophene)                Sanofi Pharmaceuticals, Inc.             
NDA 18-217                 Suprol (suprofen) Capsules, 200 mg          R. W. Johnson Pharmaceutical Research    
                                                                        Institute, 920 Rt. 202 South, P.O. Box  
                                                                        300, Raritan, NJ 08869-0602.            
NDA 18-660                 10% Travamulsion (Intravenous Fat           Baxter Healthcare Corp., Rt. 120 and     
                            Emulsion)                                   Wilson Rd., Round Lake, IL 60073.       
NDA 18-719                 Modrastane (trilostane) Capsules            Sanofi Pharmaceuticals, Inc.             
NDA 19-358                 Azo Gantrisin (sulfisoxazole and            Hoffman-La Roche, Inc.                   
                            phenazopyridine hydrochloride) Tablets                                              
ANDA 60-734                BACIGUENT Ophthalmic Ointment (Bacitracin   Pharmacia & Upjohn Co., 7000 Portage Rd.,
                            Ophthalmic Ointment, USP)                   Kalamazoo, MI 49001-0199.               
ANDA 62-036                Aerosporin (Polymyxin B Sulfate Sterile     Glaxo Wellcome, Inc., Five Moore Dr.,    
                            Powder)                                     P.O. Box 13398, Research Triangle Park, 
                                                                        NC 27709.                               
ANDA 62-363                Cleocin T Topical Solution (Clindamycin     Pharmacia & Upjohn Co.                   
                            Phosphate Topical Solution, USP)                                                    
ANDA 62-479                Doxycycline Hyclate Capsules USP, 50 mg     Purepac Pharmaceutical Co. 200 Elmora    
                            and 100 mg (Base)                           Ave., Elizabeth, NJ 07207.              
ANDA 62-913                Clindamycin Phosphate Injection USP, 150    Marsam Pharmaceuticals, Inc., Bldg. 31,  
                            mg/milliliter (mL)                          Olney Ave., P.O. Box 1022, Cherry Hill, 
                                                                        NJ 08034.                               
ANDA 70-053                Betamethasone Valerate Cream USP, 0.1%      Clay-Park Labs, Inc., 1700 Bathgate Ave.,
                                                                        Bronx, NY 10457.                        
ANDA 70-829                Methyldopa and Hydrochlorothiazide Tablets  Invamed, Inc., 2400 Rt. 130 North,       
                            USP, 250 mg/15 mg                           Dayton, NJ 08810.                       
ANDA 70-830                Methyldopa and Hydrochlorothiazide Tablets  Do.                                      
                            USP, 250 mg/25 mg                                                                   
ANDA 70-850                Metoclopramide Tablets USP, 10 mg           Do.                                      
ANDA 70-949                Metoclopramide Oral Solution USP, Eq. 5 mg  Morton Grove Pharmaceuticals, Inc., 6451 
                            Base/5 mL                                   West Main St., Morton Grove, IL 60053.  
ANDA 71-071                Haloperidol Tablets USP, 0.5 mg             Purepac Pharmaceutical Co.               
ANDA 71-072                Haloperidol Tablets USP, 1 mg               Do.                                      
ANDA 71-073                Haloperidol Tablets USP, 2 mg               Do.                                      
ANDA 71-074                Haloperidol Tablets USP, 5 mg               Do.                                      
ANDA 71-075                Haloperidol Tablets USP, 10 mg              Do.                                      
ANDA 71-076                Haloperidol Tablets USP, 20 mg              Do.                                      
ANDA 71-658                Propranolol Hydrochloride Tablets USP, 10   Invamed, Inc.                            
                            mg                                                                                  
ANDA 71-687                Propranolol Hydrochloride Tablets USP, 20   Do.                                      
                            mg                                                                                  
ANDA 71-688                Propranolol Hydrochloride Tablets USP, 40   Do.                                      
                            mg                                                                                  
ANDA 71-689                Propranolol Hydrochloride Tablets USP, 80   Do.                                      
                            mg                                                                                  
ANDA 71-811                Naloxone Hydrochloride Injection USP, 0.4   Marsam Pharmaceuticals, Inc.             
                            mg/mL                                                                               
ANDA 71-812                Methyldopate Hydrochloride Injection USP,   Do.                                      
                            50 mg/mL                                                                            
ANDA 71-938                Ibuprofen Tablets USP, 800 mg               Invamed, Inc.                            
ANDA 72-064                Ibuprofen Tablets USP, 400 mg               Do.                                      
ANDA 72-065                Ibuprofen Tablets USP, 600 mg               Do.                                      
ANDA 72-109                Doxepin Hydrochloride Capsules, 25 mg       Purepac Pharmaceutical Co.               
ANDA 72-197                Propranolol Hydrochloride Tablets USP, 60   Invamed, Inc.                            
                            mg                                                                                  
ANDA 72-198                Propranolol Hydrochloride Tablets USP, 90   Do.                                      
                            mg                                                                                  
ANDA 72-233                Verapamil Hydrochloride Injection USP, 2.5  Marsam Pharmaceuticals, Inc.             
                            mg/mL (ampuls)                                                                      
ANDA 72-371                Diazepam Injection USP, 5 mg/mL, 2 mL       Do.                                      
                            (ampul)                                                                             
ANDA 72-436                Metoclopramide Tablets USP, 5 mg            Invamed, Inc.                            
ANDA 72-516                Haloperidol Injection USP, 5 mg/mL, 1 mL    Marsam Pharmaceuticals, Inc.             
                            (ampul)                                                                             
ANDA 72-517                Haloperidol Injection USP, 5 mg/mL, 10 mL   Do.                                      
                            (vial)                                                                              
ANDA 73-054                Doxepin Hydrochloride Capsules, 10 mg       Purepac Pharmaceutical Co.               
ANDA 73-055                Doxepin Hydrochloride Capsules, 50 mg       Do.                                      
ANDA 73-098                PEG-Lyte (PEG 3350 and Electrolytes for     Invamed, Inc.                            
                            Oral Solution USP)                                                                  
ANDA 73-485                Verapamil Hydrochloride Injection USP, 2.5  Marsam Pharmaceuticals, Inc.             
                            mg/mL (vials)                                                                       
ANDA 74-125                Pindolol Tablets USP, 5 mg and 10 mg        Purepac Pharmaceutical Co.               
ANDA 74-302                Albuterol Sulfate Syrup, 2 mg (base)/5 mL   Mova Pharmaceutical Corp., P.O. Box 8639,
                                                                        Caguas, PR 00726.                       
ANDA 74-510                Etoposide Injection 20 mg/mL, 50 mL         Gensia Laboratories, 19 Hughes, Irvine,  
                            Pharmacy Bulk Package                       CA 92718-1902.                          
ANDA 81-222                ADRUCIL (Flourouracil Injection, USP) 500   Pharmacia & Upjohn Co.                   
                            mg/10 mL Ampuls                                                                     

[[Page 26193]]

                                                                                                                
ANDA 81-242                FOLEX PFS (Methotrexate Sodium Injection,   Do.                                      
                            USP) 25 mg/mL                                                                       
ANDA 83-187                Afaxin (brand of vitamin A Palmitate)       Sanofi Pharmaceuticals, Inc.             
ANDA 83-237                Diphenhydarmine Hydrochloride Elixir USP    Purepac Pharmaceutical Co.               
ANDA 83-278                Propoxyphene Hydrochloride Capsules USP,    Do.                                      
                            65 mg                                                                               
ANDA 83-856                ESTRATAB (Esterified Estrogens Tablets,     Solvay Pharmaceuticals, Inc., 901 Sawyer 
                            USP) 1.25 mg                                Rd., Marietta, GA 30062.                
ANDA 83-921                Elixophyllin (Theophylline Soft Gelatin     Forest Laboratories, Inc., 909 Third     
                            Capsules, 200 mg)                           Ave., New York, NY 10022-4731.          
ANDA 84-003                Quinidine Sulfate Tablets USP, 200 mg       Purepac Pharmaceutical Co.               
ANDA 85-545                Elixophyllin (Theophylline Soft Gelatin     Forest Laboratories, Inc.                
                            Capsules, 100 mg)                                                                   
ANDA 86-826                Elixophyllin SR (Theophylline Extended-     Do.                                      
                            Release Capsules, USP) 125 mg and 250 mg                                            
ANDA 87-999                Spironolactone and Hydrochlorothiazide      Purepac Pharmaceutical Co.               
                            Tablets USP, 25 mg/25 mg                                                            
ANDA 89-284                Procainamide Hydrochloride Extended-        Invamed, Inc.                            
                            Release Tablets USP, 500 mg                                                         
ANDA 89-463                Promethazine Hydrochloride Injection USP,   Marsam Pharmaceuticals, Inc.             
                            25 mg/mL                                                                            
ANDA 89-477                Promethazine Hycrochloride Injection USP,   Do.                                      
                            50 mg/mL                                                                            
ANDA 89-501                Phenytoin Sodium Injection USP, 50 mg/mL,   Do.                                      
                            2 mL (ampul)                                                                        
ANDA 89-511                Codaphen (Acetaminophen and Codeine         Roxane Laboratories, Inc.                
                            Phosphate Tablets USP) 500 mg/15 mg                                                 
ANDA 89-512                Codaphen (Acetaminophen and Codeine         Do.                                      
                            Phosphate Tablets USP) 500 mg/30 mg                                                 
ANDA 89-513                Codaphen (Acetaminophen and Codeine         Do.                                      
                            Phosphate Tablets USP) 500 mg/60 mg                                                 
ANDA 89-563                Chlorpromazine Hydrochloride Injection      Marsam Pharmaceuticals, Inc.             
                            USP, 25 mg/mL                                                                       
ANDA 89-675                Prochlorperazine Edisylate Injection USP,   Do.                                      
                            5 mg/mL                                                                             
ANDA 89-779                Phenytoin Sodium Injection USP, 50 mg/mL,   Do.                                      
                            2 mL and 5 mL (vials)                                                               
ANDA 89-849                Methocarbamol Injection USP, 100 mg/mL      Do.                                      
----------------------------------------------------------------------------------------------------------------

    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 
June 11, 1998.

    Dated: April 28, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-12613 Filed 5-11-98; 8:45 am]
BILLING CODE 4160-01-F