Posted by Michael Wonder on 09 Mar 2020
Athenex announces FDA acceptance for filing of U.S. NDA for tirbanibulin ointment in actinic keratosis
9 March 2020 - PDUFA date of 30 December 2020.
Athenex announced today that the U.S. FDA has completed its filing review and determined that the Company’s new drug application for tirbanibulin ointment (formerly known as KX2-391 or KX-01 ointment) for the treatment of actinic keratosis is sufficiently complete to permit a substantive review.
Additionally, the FDA has communicated that it is not currently planning on holding an advisory committee to discuss the application.
