[Federal Register Volume 61, Number 52 (Friday, March 15, 1996)]
[Notices]
[Pages 10768-10769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6174]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0075]


Hance Brothers and White Co., et al.; Proposal to Withdraw 
Approval of 17 Abbreviated 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 3 abbreviated antibiotic applications (AADA's) and 14 abbreviated 
new drug applications (ANDA'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 April 15, 1996; data 
and information in support of the hearing request are due by May 14, 
1996.

ADDRESSES: Requests for a hearing, supporting data, and other comments 
should be identified with Docket No. 96N-0075 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 AADA's and ANDA'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.


                                                                        
------------------------------------------------------------------------
         Application no.                 Drug              Applicant    
------------------------------------------------------------------------
AADA............................  Neomycin and        Hance Brothers and
                                   Polymyxin.          White Co.        
60-276..........................  B Sulfates and      ..................
                                   Bacitracin                           
                                   Ointment.                            
AADA............................  Tetracycline......  Premo             
                                                       Pharmaceutica    
                                                       Laboratories,    
                                                       Inc.             
60-422..........................  Hydrochloride       ..................
                                   Tablets.                             
AADA............................  Erythromycin        Life Laboratories,
                                   Estolate.           Inc.             
62-362..........................  Suspension, 250...  ..................
                                  Milligrams (mg)     ..................
                                   per 5.                               
                                  Milliliters (mL)..  ..................
ANDA............................  Isoniazid Tablets,  Everylife.        
                                   300 mg.                              
80-126-.........................  ..................  ..................
ANDA............................  Cyanocobalamin      Dell Laboratories,
                                   Injection.          Inc.             
80-689..........................  USP, 30 micrograms  ..................
                                  (g) per    ..................
                                   mL, 100 g/mL,.                             
 and 100 g/mL..........  ..................  ..................
ANDA............................  Lidocaine           Do.               
                                   Hydrochloride.                       
83-387..........................  Injection USP, 1%.  ..................
ANDA............................  Lidocaine           Do.               
                                   Hydrochloride.                       
83-388..........................  Injection USP, 2%.  ..................
ANDA............................  Vitamin A Capsules  Wharton           
                                   USP.                Laboratories.    
83-665..........................  ..................  ..................
ANDA............................  Pyridoxine          Dell Laboratories,
                                   Hydrochloride.      Inc.             
83-771..........................  Injection USP, 50.  ..................
                                  mg/mL.............  ..................
ANDA............................  Pyridoxine          Do.               
                                   Hydrochloride.                       
83-772..........................  Injection USP, 100  ..................
                                   mg/mL.                               
ANDA............................  Thiamine            Do.               
                                   Hydrochloride.                       
83-775..........................  Injection USP, 100  ..................
                                   mg/mL.                               
ANDA............................  Chlorpheniramine    Newtron           
                                   Maleate-.           Pharmaceuticals, 
                                                       Inc              
86-519..........................  Tablets, USP, 4 mg- ..................
                                   .                                    
ANDA............................  Brompheniramine     Do.               
                                   Maleate.                             
86-987..........................  Tablets, USP, 4 mg  ..................
ANDA............................  Fluorouracil        Marcher           
                                   Injection,.         Laboratories,    
                                                       Ltd.             
87-791..........................  50 mg/mL..........  ..................
ANDA............................  Hydrocodone         Abana             
                                   Bitartrate.         Pharmaceuticals, 
                                                       Inc.             
88-871..........................  and Acetaminophen,  ..................
                                  5 mg/500mg........  ..................
ANDA............................  Acetaminophen and   Superpharm Corp.  
                                   Codeine.                             
89-184..........................  Phosphate Tablets,  ..................
                                   USP, 300 mg/30 mg.                   
ANDA............................  Meprobamate         K. M. Lee         
                                   Tablets, USP, 400   Laboratories     
                                   mg.                                  
89-538..........................  ..................  ..................
------------------------------------------------------------------------

     Therefore, notice is given to the holders of the AADA's and ANDA'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 
AADA's and ANDA's and all amendments and supplements thereto on the 
ground that the applicants have

[[Page 10769]]
failed to submit reports required under Sec. 314.81.
    In accordance with section 505 of the act and 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 15, 1996, a written notice of participation 
and request for a hearing, and (2) on or before May 14, 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 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 a 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 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: February 28, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-6174 Filed 3-14-96; 8:45 am]
BILLING CODE 4160-01-F