[Federal Register Volume 59, Number 149 (Thursday, August 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18971]


[[Page Unknown]]

[Federal Register: August 4, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0287]

 

Glaxo, Inc., et al.; Withdrawal of Approval of 13 Abbreviated 
Antibiotic Applications and 2 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 13 abbreviated antibiotic applications (AADA's) and 2 abbreviated 
new drug applications (ANDA's). The holders of the applications 
notified the agency in writing that the drug products were no being 
longer marketed and requested that the approval of the applications be 
withdrawn.

EFFECTIVE DATE: September 6, 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 applications listed in 
the table below have informed FDA that these drug products are no 
longer being marketed and have requested that FDA withdraw approval of 
the applications. The applicants have also, by request, waived their 
opportunity for a hearing.

------------------------------------------------------------------------
   Application no.              Drug                    Applicant       
------------------------------------------------------------------------
AADA 61-231           Crystalline Penicillin G  Glaxo, Inc., Five Moore 
                       Potassium (bulk).         Dr., P.O. Box 13358,   
                                                 Research Triangle Park,
                                                 NC 27709.              
AADA 61-232           Crystalline Penicillin G  Do.                     
                       Sodium (bulk).                                   
AADA 61-324           Penicillin G Procaine     Do.                     
                       (bulk).                                          
AADA 61-491           Penicillin G Procaine     Do.                     
                       Type ``A'' (bulk).                               
AADA 61-705           Tetracycline              The Upjohn Co., 7000    
                       Hydrochloride Tablets,    Portage Rd., Kalamazoo,
                       U.S.P., 250 milligrams    MI 49001.              
                       (mg) and 500 mg.                                 
AADA 61-743           Erythromycin Stearate     Purepac Pharmaceutical  
                       Tablets, U.S.P., 250 mg.  Co., 200 Elmora Ave.,  
                                                 Elizabeth, NJ 07207.   
AADA 61-945           Sterile Penicillin G      Glaxo, Inc.             
                       Potassium Buffered                               
                       (bulk).                                          
AADA 629-053          Rifampin, U.S.P.,         Marion Merrill Dow,     
                       (nonsterile bulk).        Inc., Marion Park Dr., 
                                                 Kansas City, MO 64134- 
                                                 0627.                  
AADA 62-213           Sterile Penicillin G      Glaxo, Inc.             
                       Sodium Buffered (bulk).                          
AADA 62-297           Ampicillin for Oral       Bristol-Myers Co., P.O. 
                       Squibb,                   Box 4755, Syracuse, NY 
                       Suspension,U.S.P., 125    13221-4755.            
                       mg/5 milliliters (mL)                            
                       and 250 mg/5 mL.                                 
AADA 62-399           Neomycin and Polymyxin B  Pharmafair, Inc., 110   
                       Sulfates and              Kennedy Dr., Hauppauge,
                       Hydrocortisone Otic       NY 11788.              
                       Suspension, U.S.P..                              
AADA 62-404           Sterile Cephalothin       Glaxo, Inc.             
                       Sodium, U.S.P. (bulk).                           
AADA 62-435           Cephalothin Sodium for    Do.                     
                       Injection, U.S.P..                               
ANDA 88-101           Naphazoline               Pharmafair, Inc.        
                       Hydrochloride                                    
                       Ophthalmic Solution,                             
                       U.S.P., 0.1%.                                    
ANDA 88-230           Tropicamide Ophthalmic    Do.                     
                       Solution, U.S.P., 1%.                            
------------------------------------------------------------------------

    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 above, and all amendments and 
supplements thereto, is hereby withdrawn, effective September 6, 1994.

    Dated: July 26, 1994.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 94-18971 Filed 8-3-94; 8:45 am]
BILLING CODE 4160-01-F