Posted by Michael Wonder on 20 Jul 2019
Biohaven's Nurtec (riluzole) 505(B)2 application for amyotrophic lateral sclerosis affected by issues related to Apotex plant: complete response letter received from FDA
20 July 2019 - FDA cited issues with the active pharmaceutical ingredient used in the Biohaven 2017 bioequivalence study that was manufactured between 2014 and 2016 in an Apotex facility.
Biohaven Pharmaceutical Holding Company today announced that it has received a complete response letter from the FDA for the 505(b)2 application seeking approval for Nurtec (riluzole) for ALS.
