2019-16885. New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of withdrawal.

SUMMARY:

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

DATES:

Withdrawal of approval is effective August 19, 2019.

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:

Boehringer Ingelheim Animal Health USA Inc., 3239 Satellite Blvd., Duluth, GA 30096, has requested that FDA withdraw approval of NADA 141-054 for use of LINCOMIX (lincomycin hydrochloride) and IVOMEC (ivermectin) Type A medicated articles in the manufacture of 2-way, combination drug Type C medicated swine feeds because the product is no longer manufactured or marketed.

Also, Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 141-337 for use of RECOVYRA (fentanyl) Transdermal Solution for Dogs because the product is 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notice is given that approval of NADAs 141-054 and NADA 141-337, and all supplements and amendments thereto, is hereby withdrawn, effective August 19, 2019.

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

Dated: August 1, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.