[Federal Register Volume 61, Number 183 (Thursday, September 19, 1996)]
[Notices]
[Pages 49327-49329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24075]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0074]


Sperti Drug Products, Inc., et al.; Withdrawal of Approval of 40 
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing 40 new 
drug applications (NDA's). The basis for the withdrawals is that the 
holders of the applications have repeatedly failed to file required 
annual reports on these NDA's.

EFFECTIVE DATE: September 19, 1996.
FOR FURTHER INFORMATION CONTACT: Olivia A. Vieira, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1046.

SUPPLEMENTARY INFORMATION: The holders of approved applications to

[[Page 49328]]

market new drugs or antibiotics for human use are required to submit 
annual reports to FDA concerning each of their approved applications in 
accordance with Sec. 314.81 (21 CFR 314.81).
    In the Federal Register of March 12, 1996 (61 FR 9999), FDA offered 
an opportunity for a hearing on a proposal to withdraw approval of 41 
NDA's because the firms had failed to submit the required annual 
reports for these NDA's.
    The agency received one request for a hearing from ConvaTec, P.O. 
Box 147, St. Louis, MO 63166-0147, the firm that bought Calgon Vestal 
Laboratories. ConvaTec has filed an annual report for 17-424, Septisol 
Foam. Therefore, approval of this NDA is not being withdrawn.
    The holders of the other 40 applications did not respond to the 
notice of opportunity for hearing. Failure to file a written notice of 
participation and request for a hearing as required by 21 CFR 314.200 
constitutes an election by the applicant not to make use of the 
opportunity for a hearing concerning the proposal to withdraw approval 
of the applications and a waiver of any contentions concerning the 
legal status of the drug products. Therefore, the Director, Center for 
Drug Evaluation and Research, is withdrawing approval of the NDA's 
listed in the table in this document.

                                                                        
------------------------------------------------------------------------
             NDA no.                     Drug              Applicant    
------------------------------------------------------------------------
NDA 4-749.......................  Bio-Dyne Ointment.  Sperti Drug       
                                                       Products, Inc.   
NDA 8-532.......................  Nicodrin Tablets..  Gold Leaf         
                                                       Division, Ormont 
                                                       Drug and Chemical
                                                       Co., Inc.        
NDA 8-685.......................  Puran Tablets.....  Pure Laboratories,
                                                       Inc.             
NDA 8-891.......................  Buffered Parasal-   Panray Division,  
                                   INH and INH 20      Ormont Drug and  
                                   Tablets.            Chemical Co.,    
                                                       Inc.             
NDA 10-353......................  Parasal-Potassium   Do.               
                                   Tablets.                             
NDA 11-902......................  Hematainer........  Courtland         
                                                       Laboratories.    
NDA 12-432......................  Meprobamate         Gyma Labs.        
                                   Tablets.                             
NDA 12-435......................  Nitrofurantoin      Do.               
                                   Tablets.                             
NDA 12-513......................  Petranquil          Pharmaceutical    
                                   (Meprobamate)       Philadelphia and 
                                   Tablets.            Cosmetic Co.     
NDA 12-866......................  Meprobamate         Riverton          
                                   Tablets.            Laboratories.    
NDA 12-984......................  Secret Cream        The Procter and   
                                   Deodorant.          Gamble Co.       
NDA 14-344......................  Meprobamate         Bryant            
                                   Tablets.            Pharmaceutical,  
                                                       Corp.            
NDA 14-364......................  Meprobamate         Bates             
                                   Tablets.            Laboratories,    
                                                       Inc.             
NDA 14-365......................  Meprobamate         Philadelphia      
                                   Tablets.            Laboratories,    
                                                       Inc.             
NDA 14-367......................  Meprobamate         American          
                                   Tablets.            Pharmaceutical   
                                                       Co., Inc.        
NDA 14-368......................  Meprobamate         MK Laboratories,  
                                   Tablets.            Inc.             
NDA 14-509......................  Meprobamate         Chase Chemical Co.
                                   Tablets.                             
NDA 14-511......................  Meprobamate         Davis-Edwards     
                                   Tablets.            Pharmacal Corp.  
NDA 14-600......................  Meprobamate         Vitamix           
                                   Tablets.            Pharmaceuticals, 
                                                       Division of      
                                                       Philadelphia     
                                                       Pharmaceutical   
                                                       and Cosmetic Co. 
NDA 14-769......................  Meprobamate         USV               
                                   Tablets.            Pharmaceuticals. 
NDA 14-862......................  Meprobamate         Gold Leaf         
                                   Tablets.            Pharmacal Co.,   
                                                       Inc.             
NDA 15-081......................  Meprobamate         Kirkman           
                                   Tablets.            Laboratories,    
                                                       Inc.             
NDA 15-170......................  Meprobamate         Schlicksup Drug   
                                   Tablets.            (FAS-CILE 400 and
                                                       FAC-CILE 200)    
                                                       Co., Inc.        
NDA 15-437......................  Meprobamate         Phoenix           
                                   Tablets.            Laboratories,    
                                                       Inc.             
NDA 16-051......................  Meprobamate         Lit Drug Co.      
                                   Tablets.                             
NDA 16-068......................  Meprobamate         Leeds-Dixon       
                                   Tablets.            Laboratories,    
                                                       Inc.             
NDA 16-107......................  Protran             Rand Laboratories,
                                   *COM001*(Meprobam   Inc.             
                                   ate)Tablets.                         
NDA 16-254......................  Meprobamate         Modern Drugs, Inc.
                                   Tablets.                             
NDA 16-731......................  Cuticura Medicated  Purex.            
                                   Soap.                                
NDA 17-240......................  Bio/Dopa            Steri-Med.        
                                   (Levodopa)                           
                                   Capsules.                            
NDA 17-343......................  Actin-N             Sherwood Medical  
                                   NitrofurazoneTopi   Co.              
                                   cal Dressing.                        
NDA 17-417......................  Westasept Topical   West Chemical     
                                   Solution.           Products, Inc.   
NDA 17-418......................  Wescohex Emulsion.  Do.               
NDA 17-419......................  Wescohex Topical    The Vitarine Co., 
                                   Emulsion.           Inc.             
NDA 17-423......................  Septisol Solution.  Calgon Vestal     
                                                       Laboratories.    
NDA 17-460......................  Septi-Soft          Do.               
                                   Solution.                            
NDA 17-540......................  Heparin Sodium      Dell Laboratories.
                                   Injection.                           
NDA 17-544......................  Dancon              The Wella Corp.   
                                   Antidandruff                         
                                   Shampoo.                             
NDA 17-580......................  Dancon              Do.               
                                   Antidandruff                         
                                   Shampoo.                             
NDA 18-363......................  Hexascrub Sponge..  Professional      
                                                       Disposables,     
                                                       Inc., Division of
                                                       Nice-Pak         
                                                       Products, Inc.   
------------------------------------------------------------------------

    The Director, Center for Drug Evaluation and Research, under 
section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(e)), and under authority of 21 CFR 5.82, finds that the holders of 
the applications listed above have repeatedly failed to submit reports 
required by Sec. 314.81. Therefore, under this finding, approval of the 
NDA's listed above, and all amendments and supplements thereto, is 
hereby withdrawn, effective September 19, 1996.


[[Page 49329]]


    Dated: August 28, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-24075 Filed 9-18-96; 8:45 am]
BILLING CODE 4160-01-F