[Federal Register Volume 59, Number 26 (Tuesday, February 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2755]


[[Page Unknown]]

[Federal Register: February 8, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93N-0460]

 

Wyeth-Ayerst Laboratories, et al.; Withdrawal of Approval of 
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 four new animal drug applications (NADA's) held by Wyeth-Ayerst 
Laboratories, Pharmachem Corp., Sanofi Animal Health, Inc., and Squire 
Laboratories, Inc. The sponsors notified the agency in writing that the 
animal drug products are no longer 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of the applications be withdrawn.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 regulations 
by removing the entries which reflect approval of the NADA's.

EFFECTIVE DATE: February 18, 1994

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0749.

SUPPLEMENTARY INFORMATION: The sponsors of the NADA's listed in the 
table in this document have informed FDA that these animal drug 
products are no longer marketed or distributed and have requested that 
FDA withdraw approval of the applications. 

------------------------------------------------------------------------
        NADA No.                   Drug                   Sponsor       
------------------------------------------------------------------------
10-783.................  Promazine hydrochloride  Wyeth-Ayerst          
                          tablets.                 Laboratories P.O. Box
                                                   8299, Philadelphia., 
                                                   PA 19101             
11-871.................  Iron dextran injectable  Pharmachem Corp., P.O.
                                                   Box 1035, Bethlehem, 
                                                   PA 18018             
132-137................  Nitrofurazone solution.  Sanofi Animal Health, 
                                                   Inc., 7101 College   
                                                   Blvd., suite 610,    
                                                   Overland Park, KS    
                                                   66210                
138-455................  Nitrofurazone solution.  Squire Laboratories,  
                                                   Inc., 100 Mill St.,  
                                                   Revere, MA 02151     
------------------------------------------------------------------------

    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 10-783, 11-871, 132-137, and 138-455 and all 
supplements and amendments thereto is hereby withdrawn, effective 
February 18, 1994.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is removing the text of and reserving 21 CFR 520.1962(b) 
and amending 21 CFR 524.1580d(b) to reflect the withdrawal of approval 
of NADA's 10-783 and 138-455, respectively. It is unnecessary to amend 
the regulations to reflect withdrawal of approval of the other two 
NADA's because NADA 11-871 was never codified and the sponsor of NADA 
132-137 (Sanofi) has been previously removed from the regulation.

    Dated: January 31, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-2755 Filed 2-7-94; 8:45 am]
BILLING CODE 4160-01-F