Alpharma, Inc.; Withdrawal of Approval of NADA

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) held by Alpharma, Inc. The NADA 111-637 provides for use of tylosin Type A medicated articles to make Type C medicated swine, beef cattle, and chicken feeds. Alpharma, Inc., holds NADA 46-415 that also provides for use of tylosin Type A medicated articles to make Type C medicated swine, beef cattle, and chicken feeds. Therefore, this withdrawal of approval does not require amending the animal drug regulations.

EFFECTIVE DATE:

August 13, 2001.

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:

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, is sponsor of NADA 111-637. The NADA provides for use of tylosin Type A medicated articles to make Type C medicated swine, beef cattle, and chicken feeds. The firm requested that approval of the NADA be withdrawn because the product is no longer manufactured or marketed.

Therefore, under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10), and further redelegated to the Center for Veterinary Medicine (21 CFR 5.84), and in accordance with 21 CFR 514.115 Withdrawal of approval of applications (21 CFR 514.115), notice is given that approval of NADA 111-637 and all supplements and amendments are withdrawn, effective August 13, 2001.

Alpharma, Inc., holds NADA 46-415 that also provides for use of tylosin Type A medicated articles to make Type C medicated swine, beef cattle, and chicken feeds. Therefore, withdrawal of approval of NADA 111-637 does not require amending the animal drug regulations in 21 CFR 558.625(b)(54).