USFDA Target Action Date for Trastuzumab reset to December 3, 2017
Bengaluru, Karnataka, India, August 30, 2017:
“The US FDA has notified our partner Mylan that they will extend the target action date for their Trastuzumab 351(k) application to Dec 3, 2017 in order to review some of the clarificatory information submitted to them as a part of the application review process. This three month extension has no impact on the anticipated timetable for commercialization of this product in the U.S ”
