Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of the single NADA of the three that is codified.
Withdrawal of approval is effective May 17, 2010.Start Further Info Start Printed Page 24720
FOR FURTHER INFORMATION CONTACT:
John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
The following sponsors have requested that FDA withdraw approval of the three NADAs listed in Table 1:
|Sponsor||NADA No./Product (Established Name of Drug)||21 CFR Cite (Sponsor's Drug Labeler Code)|
|Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017||NADA 13-467/ALBAMIX Susceptibility Disks (novobiocin)||Not codified|
|Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017||NADA 45-738/LINCOMIX/BONAID (lincomycin/buquinolate)||Not codified|
|Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812||NADA 42-117/Purina 6 Day Worm-Kill Concentrate (coumaphos)||558.185 (017800)|
Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 13-467, 42-117, and 45-738, and all supplements and amendments thereto, is hereby withdrawn, effective May 17, 2010.
In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of NADA 42-117.Start Signature
Dated: April 30, 2010.
Director, Center for Veterinary Medicine.
[FR Doc. 2010-10567 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S