Department Of Health And Human Services
Conditionally Approved New Animal Drugs for Minor Use and Minor Species; Masitinib
June 15, 2012 - 77 FR 35837 - RIN: - Download Full Notice: Text | PDF
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a conditionally approved supplemental application for conditional approval of a new animal drug (CNADA) intended for a minor use filed by AB Science. The supplemental CNADA provides for a revised indication for masitinib mesylate tablets in dogs.
Agency Contact: Steven Fleischer, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8234, email: steven.fleischer@fda.hhs.gov.
This rule is final. Its effective date is June 15, 2012.
Related Links
Submit links with information related to this regulation and your link will appear right here on this page. Agency docs, academic and industry reports, news articles are all appropriate.
How Can We Improve?
We want to make OpenRegs.com as useful tool for everyone interested in regulation. Please help us improve by sending us your comments and suggestions.
OpenRegs.com is an easy-to-navigate regulatory portal. Every day, federal agencies issue dozens of rules that affect you, your business, and your family. We make it easy to keep track of proposed and final regulations and to submit comments to the agencies, so that citizens can become better informed and more involved in the regulatory process.
