[Federal Register Volume 60, Number 189 (Friday, September 29, 1995)]
[Notices]
[Pages 50627-50628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24156]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0319]


Roche Pharmaceutical Inc., et al.; Withdrawal of Approval of 13 
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 new drug applications (NDA's). The holders of the NDA's notified 
the agency in writing that the drug products were no longer being 
marketed under the NDA and requested that the approval of the 
applications be withdrawn.

EFFECTIVE DATE: September 29, 1995.

FOR FURTHER INFORMATION CONTACT: Nancy Maizel, Center for Drug 
Evaluation and Research (HFD-53), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2623.

SUPPLEMENTARY INFORMATION: The holders of the NDA's listed below have 
informed FDA that these drug products are no longer being marketed 
under the NDA and requested that FDA withdraw approval of the 
applications. The applicants have also, by request, waived their 
opportunity for a hearing.

------------------------------------------------------------------------
   NDA No.                 Drug                       Applicant         
------------------------------------------------------------------------
8-414........  Gantrisin Ophthalmic          Roche Pharmaceuticals,     
                Ointment.                     Division of Hoffmann-La   
                                              Roche Inc., 340 Kingsland 
                                              St., Nutley, NJ 07110-    
                                              1199.                     
18-996.......  Actifed 12-Hour Capsules....  Burroughs Wellcome Co.,    
                                              3030 Cornwallis Rd., P.O. 
                                              Box 12700, Research       
                                              Triangle Park, NC 27709-  
                                              2700.                     
50-102.......  Dynapen for Injection.......  Apothecon, Bristol-Myers   
                                              Squibb Co., P.O. Box 4500,
                                              Princeton, NJ 08543-4500. 
50-117.......  Staphcillin Injection.......      Do.                    
50-118.......  Prostaphlin Capsules........      Do.                    
50-167.......  Polysporin Aerosol Spray....  Burroughs Wellcome Co.     
50-176.......  Neosporin Cream.............      Do.                    
50-191.......  Tegopen Capsules............  Apothecon.                 

[[Page 50628]]
                                                                        
50-192.......  Tegopen Powder for Oral           Do.                    
                Solution.                                               
50-194.......  Prostaphlin Powder for Oral       Do.                    
                Solution.                                               
50-195.......  Prostaphlin (Oxacillin            Apothecon.             
                Sodium) for Injection.                                  
50-308.......  Polycillin (Ampicillin)           Do.                    
                Powder for Oral Solution.                               
50-337.......  Dynapen for Oral Suspension.      Do.                    
------------------------------------------------------------------------


    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 of the Center for Drug Evaluation and Research (21 CFR 5.82), 
approval of the NDA's listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective September 29, 1995.

    Dated: September 21, 1995.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 95-24156 Filed 9-28-95; 8:45 am]
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