RTTNews | Dec 29, 2020 07:10AM EST

07:09 Tuesday, December 29, 2020 (RTTNews.com) - Alkermes plc (ALKS) said the FDA has acknowledged receipt of the company's New Drug Application resubmission for ALKS 3831 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. The new PDUFA target action date is June 1, 2021.

ALKS 3831 is composed of samidorphan, a new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

Read the original article on RTTNews ( https://www.rttnews.com/3156537/alkermes-fda-sets-pdufa-action-date-of-june-1-for-alks-3831-quick-facts.aspx)

For comments and feedback: contact editorial@rttnews.com

Copyright(c) 2020 RTTNews.com All Rights Reserved