[Federal Register Volume 61, Number 80 (Wednesday, April 24, 1996)]
[Notices]
[Pages 18151-18152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10022]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 90N-0330]


The Kasdenol Corp., et al.; Withdrawal of Approval of Three New 
Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing three 
new drug applications (NDA's) held by The Kasdenol Corp.; Lever 
Brothers Co., Inc.; and United Pharmaceutical Inc. The basis for the 
withdrawals is that the holders of the applications have repeatedly 
failed to

[[Page 18152]]

file required annual reports on these NDA's.

EFFECTIVE DATE: May 24, 1996.

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).
    In the Federal Register of July 13, 1990 (55 FR 28829), FDA offered 
an opportunity for a hearing on a proposal to withdraw approval of five 
NDA's because the firms had failed to submit the required annual 
reports for these NDA's.
    The agency had two responses to the notice of opportunity for 
hearing: From Astra Pharmaceutical Products, Inc.; and from The Purdue 
Frederick Co. Both responses indicated that the sponsors had previously 
submitted letters requesting voluntary withdrawal of their NDA's (NDA 
13-077 and NDA 11-160, respectively). In the Federal Register of March 
27, 1996 (61 FR 13506 at 13507), FDA published a notice that withdrew 
these applications.
    The other three firms 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.

------------------------------------------------------------------------
         Application no.                 Drug              Applicant    
------------------------------------------------------------------------
NDA 9-394.......................  Kasdenol Mouthwash  The Kasdenol      
                                   or Gargle.          Corp.,           
                                                       Huntington, NY   
                                                       11743.           
NDA 10-094......................  Pepsodent           Lever Brothers    
                                   Antiseptic          Co., Inc., 390   
                                   Mouthwash.          Park Ave., New   
                                                       York, NY 10022.  
NDA 13-397......................  Ampar SRC.........  United            
                                                       Pharmaceutical   
                                                       Inc., 1500 North 
                                                       Wilmut, Tucson,  
                                                       AZ 85712.        
------------------------------------------------------------------------

    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, pursuant to this finding, approval 
of the NDA's listed above, and all amendments and supplements thereto, 
is hereby withdrawn, effective May 24, 1996.


    Dated: April 9, 1996.
 Murray M. Lumpkin,
 Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 96-10022 Filed 4-23-96; 8:45 am]
BILLING CODE 4160-01-F