Posted by Michael Wonder on 14 Nov 2017
Theratechnologies announces decision by the FDA to extend the ibalizumab review period to 3 April 2018
13 November 2017 - Theratechnologies announced that it was notified today by its partner, TaiMed Biologics that the U.S. FDA will extend its review of the biologics license application for ibalizumab.
In a notice received today by TaiMed from the FDA, the Prescription Drug User Fee Act target action date has been extended to 3 April 2018. The three-month extension period is the FDA’s standard extension period.
On 25 October 2017, at the FDA’s request, TaiMed submitted additional documentation related to the manufacturing section of the BLA, and the FDA subsequently decided it constituted a major amendment that required an extension to the target action date, to provide time for a full review of the submission. The FDA did not request any additional information from TaiMed in this notice.
