Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is providing notice that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2015-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of conditional approval no longer in effect. SUMMARY: The Food and Drug Administration (FDA) is providing notice that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect. DATES: Conditional approval is no longer in effect as of December 15, 2015. FOR FURTHER INFORMATION CONTACT: Herman M. Schoenemann III, Center for Veterinary Medicine (HFV-108), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0652, herman.schoenemann@fda.hhs.gov . SUPPLEMENTARY INFORMATION: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Minor Use and Minor Species Animal Health Act of 2004 ( Pub. L. 108-282 ), permits conditional approval of new animal drugs for minor uses. Conditional approval of a new animal drug is effective for a 1-year period, and may be renewed for up to four additional 1-year periods. The holder of a conditionally approved new animal drug is required to submit all information necessary to support a complete new animal drug application (NADA) under section 512(b)(1) of the FD&C Act ( 21 U.S.C. 360b(b)(1) by 180 days before the termination of the fifth 1-year period of conditional approval. If FDA does not approve an NADA for the new animal drug by the termination date of the conditional appro…
Other Federal Register documents from the same docket.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib
New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate
New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of New Animal Drug Applications; Nitarsone
Citation: 81 FR 3432
