[Federal Register Volume 59, Number 48 (Friday, March 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5634]


[[Page Unknown]]

[Federal Register: March 11, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0050]

 

Lilly Research Laboratories, et al.; Withdrawal of Approval of 57 
Abbreviated Antibiotic Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 57 abbreviated antibiotic drug applications (AADA's). The holders of 
the AADA's 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be withdrawn.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: April 11, 1994.

FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug 
Evaluation and Research (HFD-360), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1038.

SUPPLEMENTARY INFORMATION: The holders of the AADA's 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.

------------------------------------------------------------------------
      AADA No.                  Drug                    Applicant       
------------------------------------------------------------------------
60-002..............  Penicillin V Potassium    Lilly Research          
                       Pulvules.                 Laboratories, Lilly    
                                                 Corporate Center,      
                                                 Indianapolis, IN 46285.
60-060..............  Ampicillin Trihydrate     SmithKline Beecham      
                       Capsules, 250 and 500     Pharmaceuticals, One   
                       milligrams (mg).          Franklin Plaza, P.O.   
                                                 Box 7929, Philadelphia,
                                                 PA 19101.              
60-129..............  Sterile Ampicillin        Valso Ltd., 11 Briga    
                       Sodium, USP (Bulk).       Lane, White Plains, NY 
                                                 10605.                 
60-132..............  Sterile Chloramphenicol   Angus Chemical Co., 1500
                       Sodium Succinate, USP.    East Lake Cook Rd.,    
                                                 Buffalo Grove, IL      
                                                 60089.                 
60-197..............  Bacitracin, USP           A.L. Laboratories, Inc.,
                       (Nonsterile Bulk).        One Executive Dr., P.O.
                                                 Box 1399 Ft. Lee, NJ   
                                                 07024.                 
60-209..............  Ampicillin for Oral       Wyeth-Ayerst            
                       Suspension, USP.          Laboratories, P.O. Box 
                                                 8299, Philadelphia, PA 
                                                 19101-8299.            
60-210..............  Griseofulvin Tablets,     Do.                     
                       USP.                                             
60-250..............  Erythromycin              Abbott Laboratories, One
                       Ethylsuccinate            Abbott Park Rd., Abbott
                       Injection, USP.           Park, IL 60064-3500.   
60-254..............  Dicloxacillin Sodium      SmithKline Beecham.     
                       Capsules.                                        
60-264..............  Tyrothricin, USP (Bulk).  Penick Corp., 158 Mt.   
                                                 Olivet Ave., Newark, NJ
                                                 07114.                 
60-278..............  Tetracycline Oral         The Upjohn Co., 7000    
                       Suspension, USP.          Portage Rd., Kalamazoo,
                                                 MI 49001.              
60-320..............  Neomycin and Polymyxin B   Do.                    
                       Sulfates and Bacitracin                          
                       Ointment, USP.                                   
60-336..............  Bacitracin Zinc and       Marion Merrell Dow,     
                       Polymyxin B Sulfate       Inc., Marion Park Dr., 
                       Ointment, USP.            P.O. Box 9627, Kansas  
                                                 City, MO 64134-0627.   
60-342..............  Tetracycline              Angus Chemical Co.      
                       Hydrochloride.                                   
60-343..............  Tetracycline               Do.                    
                       Hydrochloride.                                   
60-344..............  Tetracycline               Do.                    
                       Hydrochloride.                                   
60-364..............  Penicillin G Potassium    Bristol-Myers Squibb,   
                       Ointment.                 Pharmaceutical Research
                                                 Institute,             
                                                P.O. Box 4000,          
                                                 Princeton, NJ 08543-   
                                                 4000.                  
60-411..............  Streptomycin Suflate      Wyeth-Ayerst            
                       Injection, USP.           Laboratories Inc.      
60-414..............  Neomycin and Polymyxin B  Procter & Gamble        
                       Sulfates and Bacitracin   Pharmaceuticals, P.O.  
                       Ointment.                 Box 191, Norwich, NY   
                                                 13815-0191.            
60-415..............  Bacitracin Ointment, USP  Do.                     
60-427..............  Neomycin and Polymyxin B  Marion Merrell Dow, Inc.
                       Sulfates and Gramicidin                          
                       Ophthalmic Solution,                             
                       USP.                                             
60-459..............  Bacitracin, Neomycin      Byk-Gulden, Inc., 60    
                       Sulfate, Polymyxin B      Baylis Rd., P.O. Box   
                       Sulfate, and Diperodon    2006, Melville, NY     
                       Hydrochloride Ointment.   11747.                 
60-471..............  Tetracycline              ICN Pharmaceuticals,    
                       Hydrochloride Capsules,   Inc., ICN Plaza, 3300  
                       USP, 250 mg.              Hyland Ave., Costa     
                                                 Mesa, CA 92626.        
60-479..............  Neomycin Sulfate          The Upjohn Co.          
                       Ointment, USP.                                   
60-480..............  Neomycin Sulfate-         Do.                     
                       Flurometholone.                                  
60-481..............  Tetracyline Oral          Do.                     
                       Suspension, USP.                                 
60-515..............  Kanamycin Sulfate         Apothecon, A Bristol-   
                       Injection.                Myers Squibb Co., P.O. 
                                                 Box 4500, Princeton, NJ
                                                 08543-4500.            
60-516..............  Kanamycin Sulfate         Do.                     
                       Capsules, 500 mg.                                
60-556..............  Neomycin Sulfate, USP     Penick Corp.            
                       (Nonsterile Bulk).                               
60-558..............  Erythromycin Estolate     Lilly Research          
                       Oral Suspension, USP,     Laboratories.          
                       100 mg base/mL.                                  
60-812..............  Chloramphenicol           Marion Merrell Dow, Inc.
                       Hemisuccinate (Bulk).                            
60-828..............  Tetracycline              Valso Ltd.              
                       Hydrochloride, USP                               
                       (Bulk).                                          
60-829..............  Tetracycline, USP (Bulk)  Do.                     
61-137..............  Penicillin V (Bulk).....  Lilly Research          
                                                 Laboratories.          
61-525..............  Erythromycin Delayed-     Richmar International,  
                       Release Tablets, 250 mg.  Inc., 1706 Birch Rd.,  
                                                 McLean, VA 22101.      
61-586..............  Neomycin Sulfate          Eon Labs Manufacturing, 
                       Tablets, 500 mg.          Inc., 227-15 Conduit   
                                                 Ave., Laurelton, NY    
                                                 11413.                 
61-967..............  Chloramphenicol           Merrell Dow             
                       Palmitate (Bulk).         Pharmaceuticals, Inc., 
                                                 2110 East Galbraith    
                                                 Rd., Cincinnati, OH    
                                                 45215.                 
62-177..............  Erythromycin              Lilly Research          
                       Ethylsuccinate Oral       Laboratories.          
                       Suspension, 200 mg/5                             
                       milliliters (mL) and                             
                       400 mg/5 mL.                                     
62-261..............  Cephalexin Monohydrate    Do.                     
                       (Bulk).                                          
62-264..............  Gentamicin Sulfate        Wyeth-Ayerst            
                       Injection, USP.           Laboratories.          
62-381..............  Neomycin and Polymyxin B  Pharmafair, Inc., 110   
                       Sulfates, Bacitracin      Kennedy Dr., Hauppauge,
                       Zinc, and                 NY 11788.              
                       Hydrocortisone Topical                           
                       Ointment.                                        
62-386..............  Neomycin and Polymyxin B  Do.                     
                       Sulfates and Bacitracin                          
                       Zinc Ophthalmic                                  
                       Ointment, USP.                                   
62-389..............  Neomycin and Polymyxin B  Do.                     
                       Sulfates, Bacitracin                             
                       Zinc, and                                        
                       Hydrocortisone                                   
                       Ophthalmic Ointment,                             
                       USP.                                             
62-411..............  Neomycin and Polymyxin B  Do.                     
                       Sulfates and                                     
                       Dexamethasone                                    
                       Ophthalmic Ointment,                             
                       USP.                                             
62-428..............  Neomycin and Polymyxin B  Do.                     
                       Sulfates and                                     
                       Dexamethasone                                    
                       Ophthalmic Suspension,                           
                       USP.                                             
62-443..............  Gentamicin Sulfate        Do.                     
                       Ophthalmic Ointment,                             
                       USP, 3 mg base/gram (g).                         
62-481..............  Erythromycin Ophthalmic   Do.                     
                       Ointment, USP, 5 mg/g.                           
62-485..............  Erythromycin Topical      Do.                     
                       Solution, USP, 1.5%.                             
62-547..............  Cephalothin Sodium and    Abbott Laboratories,    
                       5% Dextrose Injection,    Inc., Hospital Products
                       USP.                      Division Abbott Park,  
                                                 IL 60064.              
62-548..............  Cephalothin Sodium and    Do.                     
                       0.9% Sodium Chloride                             
                       Injection, USP.                                  
62-603..............  Nystatin and              Pharmaderm, A Division  
                       Triamcinolone Acetonide   of Altana Inc., 60     
                       Ointment, USP.            Bayliss Rd., Melville, 
                                                 NY 11747.              
62-617..............  Neomycin and Polymyxin B  Pharmafair, Inc.        
                       Sulfates and                                     
                       Hydrocortisone Otic                              
                       Suspension.                                      
62-623..............  Neomycin and Polymyxin B  Do.                     
                       Sulfates and                                     
                       Hydrocortisone                                   
                       Ophthalmic Suspension,                           
                       USP.                                             
62-848..............  Cefadroxil, USP (Bulk)..  Valso Ltd.              
62-894..............  Sterile Cefazolin         Ben Venue Laboratories, 
                       Sodium, USP 250 mg, 500   Inc., 270 Northfield   
                       mg, 1 g, 5 g, and 10 g    Rd., P.O. Box 46568,   
                       per vial.                 Bedford, OH 44146-0568.
62-908..............  Clindamycin Phosphate     The DuPont Merck        
                       Injection, USP, 150 mg/   Pharmaceutical Co.,    
                       mL.                       1000 Stewart Ave.,     
                                                 Garden City, NY 11530. 
70-292..............  Carbachol Intraocular     Pharmafair, Inc.        
                       Solution, USP, 0.01%.                            
------------------------------------------------------------------------

    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 AADA's listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective April 11, 1994.

    Dated: February 23, 1994.
Murray M. Lumpkin,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-5634 Filed 3-10-94; 8:45 am]
BILLING CODE 4160-01-P