[Federal Register Volume 61, Number 49 (Tuesday, March 12, 1996)]
[Notices]
[Pages 9998-10000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5748]



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[[Page 9999]]


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


Sperti Drug Products, Inc., et al.; Proposal To Withdraw Approval 
of 41 New Drug Applications; Opportunity for Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is offering an 
opportunity for a hearing on the agency's proposal to withdraw approval 
of 41 new drug applications (NDA's). The basis for the proposal is that 
the sponsors have repeatedly failed to file required annual reports for 
these NDA's.

DATES: Written requests for a hearing are due by April 11, 1996; data 
and information in support of the hearing request are due by May 13, 
1996.

ADDRESSES: Requests for a hearing, supporting data, and other comments 
should be identified with Docket No. 96N-0074, and submitted to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1038.

SUPPLEMENTARY INFORMATION: The holders of approved applications to 
market new drugs or antibiotic drugs 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). The 
holders of the NDA's listed in the table below have failed to submit 
the required annual reports, and have not responded to the agency's 
requests by certified mail for submission of the reports.

                                                                        
------------------------------------------------------------------------
             NDA no.                     Drug              Applicant    
------------------------------------------------------------------------
4-749...........................  Bio-Dyne Ointment.  Sperti Drug       
                                                       Products, Inc.   
8-532...........................  Nicodrin Tablets..  Gold Leaf         
                                                       Division, Ormont 
                                                       Drug and Chemical
                                                       Co., Inc.        
8-685...........................  Puran Tablets.....  Pure Laboratories 
                                                       Inc.             
8-891...........................  Buffered Parasl-    Panray Division,  
                                   INH & INH 20        Ormont Drug and  
                                   Tablets.            Chemical Co.,    
                                                       Inc.             
10-353..........................  Parasal-Potassium   Do.               
                                   Tablets.                             
11-902..........................  Hematainer........  Courtland         
                                                       Laboratories.    
12-432..........................  Meprobamate         Gyma Labs.        
                                   Tablets.                             
12-435..........................  Nitrofurantoin      Do.               
                                   Tablets.                             
12-513..........................  Pertranquil         Philadelphia      
                                   (Meprobamate)       Pharmaceutical   
                                   Tablets.            and Cosmetic Co. 
12-866..........................  Meprobamate         Riverton          
                                   Tablets.            Laboratories.    
12-984..........................  Secret Cream        The Procter and   
                                   Deodorant.          Gamble Co.       
14-344..........................  Meprobamate         Bryant            
                                   Tablets.            Pharmaceutical,  
                                                       Corp.            
14-364..........................  Meprobamate         Bates             
                                   Tablets.            Laboratories,    
                                                       Inc.             
14-365..........................  Meprobamate         Philadelphia      
                                   Tablets.            Laboratories,    
                                                       Inc.             
14-367..........................  Meprobamate          American         
                                   Tablets.            Pharmaceutical   
                                                       Co. Inc.         
14-368..........................  Meprobamate         MK Laboratories,  
                                   Tablets.            Inc.             
14-509..........................  Meprobamate         Chase Chemical Co.
                                   Tablets.                             
14-511..........................  Meprobamate         Davis-Edwards     
                                   Tablets.            Pharmacal Corp.  
14-600..........................  Meprobamate         Vitamix           
                                   Tablets.            Pharmaceuticals, 
                                                       Division of      
                                                       Philadelphia     
                                                       Pharmaceutical   
                                                       and Cosmetic Co. 
14-769..........................  Meprobamate         USV               
                                   Tablets.            Pharmaceuticals. 
14-862..........................  Meprobamate         Gold Leaf         
                                   Tablets.            Pharmacal Co.,   
                                                       Inc.             
15-081..........................  Meprobamate         Kirkman           
                                   Tablets.            Laboratories,    
                                                       Inc.             
15-170..........................  Meprobamate         Schlicksup Drug   
                                   Tablets (FAS-CILE   Co., Inc.        
                                   400 and FAC-CILE                     
                                   200).                                
15-437..........................  Meprobamate         Phoenix           
                                   Tablets.            Laboratories,    
                                                       Inc.             
16-051..........................  Meprobamate         Lit Drug Co.      
                                   Tablets.                             
16-068..........................  Meprobamate         Leeds-Dixon       
                                   Tablets.            Laboratories,    
                                                       Inc.             
16-107..........................  Protran             Rand Laboratories,
                                   (Meprobamate)       Inc.             
                                   Tablets.                             
16-254..........................  Meprobamate         Modern Drugs, Inc.
                                   Tablets.                             
16-731..........................  Cuticura Medicated  Purex.            
                                   Soap.                                
17-240..........................  Bio/Dopa            Steri-Med.        
                                   (Levodopa)                           
                                   Capsules.                            
17-343..........................  Actin-N             Sherwood Medical  
                                   Nitrofurazone       Co.              
                                   Topical Dressing.                    
17-417..........................  Westasept Topical   West Chemical     
                                   Solution.           Products, Inc.   
17-418..........................  Wescohex Emulsion.  Do.               
17-419..........................  Wescohex Topical    The Vitarine Co., 
                                   Emulsion.           Inc.             
17-423..........................  Septisol Solution.  Calgon Vestal     
                                                       Laboratories.    
17-424..........................  Septisol Foam.....  Do.               
17-460..........................  Septi-Soft          Do.               
                                   Solution.                            
17-540..........................  Heparin Sodium      Dell Laboratories.
                                   Injection.                           
17-544..........................  Dancon              The Wella Corp.   
                                   Antidandruff                         
                                   Shampoo.                             
17-580..........................  Dancon              Do.               
                                   Antidandruff                         
                                   Shampoo.                             
18-363..........................  Hexascrub Sponge..  Professional      
                                                       Disposables Inc.,
                                                       Division of Nice-
                                                       Pak Products,    
                                                       Inc.             
------------------------------------------------------------------------

    Therefore, notice is given to the holders of the NDA's listed in 
the table and to all other interested persons that the Director of the 
Center for Drug Evaluation and Research proposes to issue an order 
under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 355(e)) withdrawing approval of the NDA's and

[[Page 10000]]
all amendments and supplements thereto on the ground that the 
applicants have failed to submit the reports required under 
Sec. 314.81.
    In accordance with section 505 of the act and part 314 (21 CFR part 
314), the applicants are hereby provided an opportunity for a hearing 
to show why the applications listed above should not be withdrawn and 
an opportunity to raise, for administrative determination, all issues 
relating to the legal status of the drug products covered by these 
applications.
    An applicant who decides to seek a hearing shall file: (1) On or 
before April 11, 1996, a written notice of participation and request 
for a hearing, and (2) on or before May 13, 1996, the data, 
information, and analyses relied on to demonstrate that there is a 
genuine and substantial issue of fact that requires a hearing. Any 
other interested person may also submit comments on this notice. The 
procedures and requirements governing this notice of opportunity for a 
hearing, notice of participation, and request for a hearing, 
information and analyses to justify a hearing, other comments, and a 
grant or denial of a hearing, are contained in Sec. 314.200 and in 21 
CFR part 12.
    The failure of an applicant to file a timely written notice of 
participation and request for a hearing, as required by Sec. 314.200, 
constitutes an election by that applicant not to avail itself of the 
opportunity for a hearing concerning the proposal to withdraw approval 
of the applications and constitutes a waiver of any contentions 
concerning the legal status of the drug products. FDA will then 
withdraw approval of the applications and the drug products may not 
thereafter lawfully be marketed, and FDA will begin appropriate 
regulatory action to remove the products from the market. Any new drug 
product marketed without an approved mew drug application is subject to 
regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or 
denials, but must present specific facts showing that there is a 
genuine and substantial issue of fact that requires a hearing. Reports 
submitted to remedy the deficiencies must be complete in all respects 
in accordance with Sec. 314.81. If the submission is not complete or if 
a request for hearing is not made in the required format or with the 
required reports, the Commissioner of Food and Drugs will enter summary 
judgment against the person who requests the hearing, making findings 
and conclusions, and denying a hearing.
    All submissions pursuant to this notice of opportunity for a 
hearing are to be filed in four copies. Except for data and information 
prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 
1905, the submissions may be seen in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m, Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (sec. 505 (21 U.S.C. 355)) and under authority delegated to the 
Director, Center for Drug Evaluation and Research (21 CFR 5.82).

    Dated: February 28, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-5748 Filed 3-11-96; 8:45 am]
BILLING CODE 4160-01-F