[Federal Register Volume 59, Number 201 (Wednesday, October 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25908]


[[Page Unknown]]

[Federal Register: October 19, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0368]

 

The Upjohn Co., et al.; Withdrawal of Approval of Seven 
Abbreviated Antibiotic Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of seven abbreviated antibiotic 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be withdrawn.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: November 18, 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     
------------------------------------------------------------------------
61-651.......................  Penicillin V          The Upjohn Co.,    
                                Potassium Tablets,    7000 Portage Rd., 
                                U.S.P., 500           Kalamazoo, MI     
                                milligrams (mg).      499001-0199.      
61-656.......................  Penicillin V          Do.                
                                Potassium for Oral                      
                                Solution, U.S.P.,                       
                                125 mg/5                                
                                milliliters (mL)                        
                                and 250 mg/5 mL.                        
61-838.......................  Penicillin G          SmithKline Beecham 
                                Potassium(nonsteril   Pharmaceuticals,  
                                e bulk, technical     Four Falls        
                                grade).               Corporate Center, 
                                                      Rt. 23 and        
                                                      Woodmont Ave.,    
                                                      P.O. Box 1510,    
                                                      King of Prussia,  
                                                      PA 19406.         
62-158.......................  Bacitracin            Pharmaderm,        
                                Ophthalmic            Division of Altana
                                Ointment, U.S.P.,     Inc., 60 Baylis   
                                500 units/gram (g).   Rd., Melville, NY 
                                                      11747.            
62-440.......................  Gentamicin Sulfate    Pharmafair, Inc.,  
                                Ophthalmic            110 Kennedy Dr.,  
                                Solution, U.S.P.,     Hauppauge, NY     
                                0.3%.                 11788.            
62-558.......................  Erythromycin          Do.                
                                Ethylsuccinate Oral                     
                                Suspension, U.S.P.,                     
                                400 mg/5 mL.                            
62-799.......................  Bacitracin Ointment,  Combe Inc., 1101   
                                U.S.P., 500 units/g.  Westchester Ave., 
                                                      White Plains, NY  
                                                      10604-3597.       
------------------------------------------------------------------------

    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 on November 18, 1994.

    Dated: October 4, 1994.
 Janet Woodcock,
 Director, Center for Drug Evaluation and Research.
[FR Doc. 94-25908 Filed 10-18-94; 8:45 am]
BILLING CODE 4160-01-F