[Federal Register Volume 59, Number 106 (Friday, June 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13593]


[[Page Unknown]]

[Federal Register: June 3, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0194]

 

Apothecon, et al.; Withdrawal of Approval of Six 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 six 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withdrawn.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: July 5, 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          
------------------------------------------------------------------------
61-911..  Kanamycin Sulfate Capsules,     Apothecon, P.O. Box 4500,     
           U.S.P. 500 miligrams (mg).      Princeton, NJ 08543-4500.    
61-981..  Neomycin and Polymyxin B        Clay-Park Labs, Inc., 1700    
           Sulfates and Bacitracin         Bathgate Ave., Bronx, NY     
           Ointment, U.S.P.                10457.                       
62-271..  Cloxacillin Sodium Capsules,    Apothecon.                    
           USP, 250 mg.                                                 
62-688..  Sterile Cefazolin Sodium,       Fujisawa USA, Inc., Three     
           U.S.P.                          Parkway North, 3d floor,     
                                           Deerfield, IL 60015-2548.    
62-957..  Erythromycin Topical Solution,  Barre-National, Inc., 333     
           USP, 2%.                        Cassell Dr., suite 3500,     
                                           Baltimore, MD 21224.         
63-010..  Nystatin and Triamcinolone      Do.                           
           Acetonide Cream, USP.                                        
------------------------------------------------------------------------

    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 July 5, 1994.

    Dated: May 24, 1994.
Murray M. Lumpkin,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-13593 Filed 6-2-94; 8:45 am]
BILLING CODE 4160-01-P