New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of withdrawal.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs). This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.

DATES:

Withdrawal of approval is effective July 24, 2017.

FOR FURTHER INFORMATION CONTACT:

Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has requested that FDA withdraw approval of NADA 065-291 for bulk dihydrostreptomycin sulfate and NADA 065-324 for bulk streptomycin sulfate because the products are no longer manufactured or marketed.

Therefore, under authority delegated to the Commissioner of Food and Drugs, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADA 065-291 and NADA 065-324, and all supplements and amendments thereto, is hereby withdrawn, effective July 24, 2017.

As neither of these NADAs was codified, the animal drug regulations do not require amendment to reflect the voluntary withdrawal of approval of these applications.