Alkermes Receives Complete Response Letter From U.S. Food & Drug Administration For ALKS 5461 New Drug Application

Alkermes plc (Alkermes) recently announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its new drug application (NDA) for ALKS 5461. ALKS 5461 is the pharmaceutical company’s adjunctive treatment for major depressive disorder (MDD).

The CRL states that the FDA is unable to approve the ALKS 5461 NDA in its present form, and is requesting additional clinical data to provide substantial evidence of effectiveness of ALKS 5461 for the treatment of MDD. Alkermes plans to meet with the FDA to discuss the contents of the CRL, as well as . . .