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 seven new animal drug applications (NADAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications.

DATES:

Withdrawal of approval is effective February 23, 2021.

FOR FURTHER INFORMATION CONTACT:

David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5720, david.alterman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

The holders of approved applications to market new animal drugs are required to submit annual reports to FDA concerning each of their approved applications in accordance with § 514.80 (21 CFR 514.80).

In the Federal Register of January 8, 2020 (85 FR 919), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of seven NADAs because the sponsors had failed to submit the required annual reports for these applications. The holders of these applications did not respond to the NOOH. Failure to file a written notice of participation and request for a hearing as required by § 514.200(b) (21 CFR 514.200(b)) constitutes an election by the applicant not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of the applications and a waiver of any contentions concerning the legal status of the drug products. Therefore, approval of the seven applications listed in table 1 is being withdrawn.

The Commissioner of Food and Drugs (the Commissioner), under section 512(e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(e)(2)(A)), finds that the holders of the applications listed in this document have repeatedly failed to submit reports required by § 514.80. In addition, under § 514.200(b), the Commissioner finds that the holders of the applications have waived any contentions concerning the legal status of the drug products. Therefore, under these findings, approval of the applications listed in this document, and all amendments and supplements thereto, is hereby withdrawn, effective February 23, 2021.

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