2017-09365. New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of withdrawal.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.

DATES:

Withdrawal of approval is effective May 22, 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, [e-mail].

SUPPLEMENTARY INFORMATION:

Sioux Biochemical, Inc., 204 Third St. NW., Sioux Center, IA 51250 has requested that FDA withdraw approval of NADA 009-505 for F.S.H.-P (follicle stimulating hormone) Powder for Injection because the product is no longer manufactured or marketed.

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(21 CFR 514.116), notice is given that approval of NADA 009-505, and all supplements and amendments thereto, is hereby withdrawn, effective May 22, 2017.

Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of this application.

Dated: May 4, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.