[Federal Register Volume 61, Number 187 (Wednesday, September 25, 1996)]
[Notices]
[Pages 50323-50324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24610]


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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.; Withdrawal of Approval of 
16 Abbreviated Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 3 
abbreviated antibiotic applications (AADA'S) and 13 abbreviated new 
drug applications (ANDA's). The basis for the withdrawals is that the 
sponsors have repeatedly failed to file required annual reports for 
these applications.

EFFECTIVE DATE:  September 25, 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 
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 15, 1996 (61 FR 10768), FDA 
offered an opportunity for a hearing on a proposal to withdraw approval 
of 17 abbreviated applications because the firms had failed to submit 
the required annual reports for these applications.
    One application holder, Superpharm Corp. notified the agency in 
writing that ANDA 89-184, Acetaminophen and Codeine Phosphate Tablets, 
is no longer marketed and requested that approval of the application be 
withdrawn. FDA withdrew approval of ANDA 89-184 in the Federal Register 
of August 5, 1996 (61 FR 40649).
    The holders of the other 16 applications did not respond to the 
notice of opportunity for a 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 applications listed in the table in this 
document.

[[Page 50324]]



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

    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 
applications listed above, and all amendments and supplements thereto, 
is hereby withdrawn, effective September 25, 1996.

    Dated: August 25, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-24610 Filed 9-24-96; 8:45 am]
BILLING CODE 4160-01-F