[Federal Register Volume 60, Number 31 (Wednesday, February 15, 1995)]
[Notices]
[Pages 8661-8662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3801]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0450]


Premiere Agri Technologies, Inc., 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 
[[Page 8662]] approval of five new animal drug applications (NADA's), 
one held by Pfizer, Inc., and four NADA's held by Premiere Agri 
Technologies, Inc. Pfizer, Inc., notified FDA that its oxytetracycline 
soluble powder is no longer marketed. Premiere Agri Technologies, Inc., 
notified FDA that its approved NADA's are no longer required to 
manufacture Type B medicated feeds containing tylosin or virginiamycin. 
For these reasons, both sponsors 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applications be withdrawn.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 27, 1995.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1722.

SUPPLEMENTARY INFORMATION: FDA has been informed by : (1) Pfizer, Inc., 
that it is no longer manufacturing or marketing its oxytetracycline 
soluble powder, and (2) Premiere Agri Technologies, Inc., that approval 
of its NADA's listed in the table is no longer required to manufacture 
Type B medicated feeds containing tylosin or virginiamycin (Type A 
medicated articles containing tylosin are covered by another NADA). 
Accordingly, both firms requested in writing that FDA withdraw approval 
of the applications.

------------------------------------------------------------------------
                                                     Sponsor name and   
        NADA No.                Drug name                 address       
------------------------------------------------------------------------
10-661.................  Oxytetracycline soluble  Pfizer, Inc., 235 East
                          powder                   42d St., New York, NY
                          (Terramycin    10017                
                          Egg Formula).                                 
45-690.................  Tylosin Type B           Premiere Agri         
                          medicated feeds and      Technologies, Inc.,  
                          Type A medicated         P.O. Box 2508, Fort  
                          article.                 Wayne, IN 46801-2508 
                                                   (former sponsor      
                                                   Henwood Feed         
                                                   Additives)           
97-289.................  Tylosin Type B           Do. (Former sponsor   
                          medicated feeds and      Feed Specialties Co.,
                          Type A medicated         Inc.)                
                          article.                                      
133-361................  Virginiamycin Type B     Do. (Former sponsor   
                          medicated feed.          Feed Specialties Co.,
                                                   Inc.)                
133-839................  Virginiamycin Type B     Do. (Former sponsor   
                          medicated feed.          MAC-PAGE, Inc.)      
------------------------------------------------------------------------

    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 10-661, 45-690, 97-289, 133-361, and 133-839 and all 
supplements and amendments thereto is hereby withdrawn, effective 
February 27, 1995.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is: (1) Amending 21 CFR 558.625 by removing and reserving 
paragraphs (b)(11) and (b)(15) to reflect the withdrawal of approval of 
NADA's 45-690 and 97-289 and (2) amending 21 CFR 558.635(b)(2) to 
reflect the withdrawal of approval of NADA's 133-361 and 133-839. It is 
unnecessary to amend the regulations to reflect withdrawal of approval 
of NADA 10-661 because it is not codified.

    Dated: January 6, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-3801 Filed 2-14-95; 8:45 am]
BILLING CODE 4160-01-F