[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that the approval of the applications be withdrawn.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.

                                                                        
------------------------------------------------------------------------
         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.                              
------------------------------------------------------------------------

    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