[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Pages 37063-37064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0263]


Global Pharmaceutical Corp. et al.; Proposal to Withdraw Approval 
of Four New Drug Applications; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Written requests for a hearing are due by August 11, 1997; data 
and information in support of the hearing request are due by September 
8, 1997.

ADDRESSES: Requests for a hearing, supporting data, and other comments 
should be identified with Docket No. 97N-0263 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: Olivia A. Vieira, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

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 
request by certified mail for submission of the reports.

                                                                        
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         Application No.                 Drug              Applicant    
------------------------------------------------------------------------
NDA 9-273.......................  Rauwolfia           Global            
                                   Serpentina          Pharmaceutical   
                                   Tablets, 50         Corp., Castor and
                                   milligrams (mg)     Kensington Aves.,
                                   and 100 mg.         Philadelphia, PA 
                                                       19124-5694.      
NDA 11-623......................  Mucilose Super      European Research 
                                   Powder.             Associates, Ltd.,
                                                       Pailinakis Bldg.,
                                                       Elisabeth Ave.,  
                                                       P.O. Box N3334,  
                                                       Nassau, N.P.,    
                                                       Bahamas.         
NDA 12-748......................  Duotrate            Jones Medical     
                                   (pentaerythritol    Industries, Inc.,
                                   tetranitrate)       1945 Craig Rd.,  
                                   Capsules, 45 mg.    St. Louis, MO    
                                                       63146.           
NDA 16-470......................  Duotrate            Do.               
                                   (pentaerythritol                     
                                   tetranitrate)                        
                                   Capsules, 30 mg.                     
------------------------------------------------------------------------

    The last two products listed, NDA's 12-748 and 16-470, were named 
in a notice of opportunity for hearing published in the Federal 
Register of October 14, 1984 (49 FR 40213), under Docket No. 87N-0262, 
proposing to withdraw the applications, along with other applicants' 
products, because they lack substantial evidence of effectiveness. In 
response to that notice, hearings were requested and a hearing was 
granted (52 FR 32170, August 26, 1987); Jones Medical, the successor in 
interest to NDA's 12-748 and 16-470, filed a Notice of Participation; 
on May 10, 1989, the Administrative Law Judge issued his Initial 
Decision, ordering that NDA's 17-748 and 16-740, and others, be 
withdrawn; Jones Medical, as well as two other parties, appealed that 
decision to the Commissioner of Food and Drugs (the Commissioner). If a 
final order on NDA's 12-748 and 16-470 is issued under the present 
matter for failing to file required annual reports, the appeal by Jones 
Medical in Docket No. 87N-0262 will be regarded as withdrawn.
    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 all 
amendments and supplements thereto on the ground that the applicants 
have failed to submit 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 August 11, 1997, a written notice of participation and request 
for a hearing, and (2) on or before September 8, 1997, the data, 
information, and analyses

[[Page 37064]]

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 hearing, notice of 
participation, and request for 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 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 new 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 will enter summary judgment against 
the person who requests the hearing, making findings and conclusions, 
and denying a hearing.
    All submissions under this notice of opportunity for a hearing must 
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: June 19, 1997.
 Janet Woodcock,
 Director, Center for Drug Evaluation and Research.
[FR Doc. 97-17977 Filed 7-9-97; 8:45 am]
BILLING CODE 4160-01-F