[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Notices]
[Pages 34848-34849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16887]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0121]


Bayer Corp., et al.; Withdrawal of Approval of 29 NADA's

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 29 new animal drug applications (NADA's). Twenty-four NADA's are 
held by Bayer Corp., Agriculture Division, Animal Health (formerly 
Miles, Inc., Agriculture Division, Animal Health Products), three are 
held by Hubbard Milling Co., and one each is held by Hoffmann-LaRoche, 
Inc., and Ohmeda, Inc. The firms notified the agency in writing that 
the animal drug products are not being manufactured or marketed and 
requested that approval of the applications be withdrawn. In a final 
rule published elsewhere in this issue of the Federal Register, FDA is 
amending the animal drug regulations by removing the entries which 
reflect approval of the NADA's.

EFFECTIVE DATE: July 15, 1996.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0159.

SUPPLEMENTARY INFORMATION: The sponsors of the applications listed in 
the table in this document have informed FDA that these animal drug 
products are not being manufactured or marketed and have requested that 
FDA withdraw approval of the applications.

                                                                        
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                                                       Sponsor name and 
           NADA no.                   Drug name             address     
------------------------------------------------------------------------
6-462.........................  Diethylcarbamazine    Bayer Corp.,      
                                 tablets.              Agriculture      
                                                       Division, Animal 
                                                       Health, P.O. Box 
                                                       390, Shawnee     
                                                       Mission, KS      
                                                       66201.           
10-540........................  Calcium disodium      Do.               
                                 edetate injection.                     
11-380........................  Diethylcarbamazine    Do.               
                                 powder.                                
12-054........................  Protokylol            Do.               
                                 hydrochloride                          
                                 tablets and                            
                                 injection.                             
12-103........................  Triamcinolone         Do.               
                                 tablets.                               
12-392........................  Triamcinolone         Do.               
                                 injection.                             
12-598........................  Disophenol sodium     Do.               
                                 injection.                             
15-161........................  Trichlorfon powder..  Do.               
15-965........................  Coumaphos Type A      Do.               
                                 medicated article.                     
30-045........................  Triamcinolone/        Do.               
                                 neomycin sulfate                       
                                 ointment.                              
34-394........................  Niclosamide tablets.  Do.               
35-263........................  Styrylpyridinium      Do.               
                                 chloride/                              
                                 diethylcarbamazine                     
                                 (as base) oral                         
                                 liquid.                                
45-287........................  Coumaphos crumbles..  Do.               
48-645........................  Tylosin Type A        Hubbard Milling   
                                 medicated articles    Co., 424 North   
                                 (5, 10, 20, and 40    Riverfront Dr.,  
                                 grams per pound).     P.O. Box 8500,   
                                                       Mankato, MN 56002-
                                                       8500.            
49-555........................  Styrylpyridinium      Bayer Corp.       
                                 chloride/                              
                                 diethylcarbamazine                     
                                 control diet HRH/                      
                                 MSD.                                   
91-628........................  Diethylcarbamazine    Do.               
                                 citrate syrup.                         
93-372........................  Chlortetracycline     Hoffmann-LaRoche, 
                                 calcium complex       Inc., Nutley, NJ 
                                 Type A medicated      07110.           
                                 articles.                              
94-402........................  Tylosin and           Hubbard Milling   
                                 sulfamethazine Type   Co.              
                                 A medicated                            
                                 articles.                              
95-078........................  Trichlorfon oral      Bayer Corp.       
                                 liquid.                                
96-031........................  Styrylpyridinium      Do.               
                                 chloride/                              
                                 diethylcarbamazine                     
                                 citrate tablets.                       
100-201.......................  Trichlorfon paste...  Do.               
100-356.......................  Styrylpyridinium      Do.               
                                 chloride/                              
                                 diethylcarbamazine                     
                                 control diet HRH.                      
100-670.......................  Niclosamide Type A    Do.               
                                 medicated article.                     
101-078.......................  Dichlorophene and     Do.               
                                 toluene capsules.                      
120-327.......................  Diethylcarbamazine    Do.               
                                 chewable tablets.                      
120-670.......................  Styrylpyridinium,     Do.               
                                 diethylcarbamazine                     
                                 edible tablets.                        

[[Page 34849]]

                                                                        
121-291.......................  Enflurane liquid      Ohmeda, Inc.,     
                                 (anesthetic).         Pharmaceutical   
                                                       Products         
                                                       Division, P.O.   
                                                       Box 804, Liberty 
                                                       Corner, NJ 07938-
                                                       0804.            
121-813.......................  Styrylpyridinium,     Bayer Corp.       
                                 diethylcarbamazine                     
                                 film-coated tablets.                   
133-509.......................  Pyrantel tartrate     Hubbard Milling   
                                 Type A medicated      Co.              
                                 articles.                              
------------------------------------------------------------------------


    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADA's 6-462, 10-540, 11-380, 12-054, 12-103, 12-392, 12-
598, 15-161, 15-965, 30-045, 34-394, 35-263, 45-287, 48-645, 49-555, 
91-628, 93-372, 94-402, 95-078, 96-031, 100-201, 100-356, 100-670, 101-
078, 120-327, 120-670, 121-291, 121-813, and 133-509, and all 
supplements and amendments thereto is hereby withdrawn, effective July 
15, 1996.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is removing 21 CFR 520.500, 520.620a, 520.620b, 520.1520, 
520.2022, 520.2160a, 520.2160b, 520.2160c, 520.2160d, 520.2480, 
520.2520c, 520.2520d, 522.281, 522.740, 522.2022, 522.2480, 529.810, 
558.367, and 558.565, and amending 21 CFR 520.580, 520.622a, 520.622b, 
520.2520a, 558.185, 558.485, 558.625, and 558.630 to reflect the 
withdrawal of approval of the above mentioned NADA's.

    Dated: June 3,1996.
Michael J. Blackwell,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 96-16887 Filed 7-2-96; 8:45 am]
BILLING CODE 4160-01-F