Posted by Michael Wonder on 29 Dec 2020
FDA accepts Alkermes' resubmission of new drug application for ALKS 3831
29 December 2020 - FDA sets PDUFA target action date of 1 June 2021.
Alkermes today announced that the U.S. FDA has acknowledged receipt of the company's new drug application resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder.
The FDA classified the resubmission as a complete, Class 2 response to the complete response letter issued in November 2020, following a remote review of records requested under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act relating to the manufacture of ALKS 3831 at the company's Wilmington, OH facility.
