Alkermes Initiates Rolling Submission Of ALKS 5461 New Drug Application For Major Depressive Disorder

Alkermes announced the initiation of a rolling submission of a New Drug Application for ALKS 5461, its once-daily medication for major depressive disorder (MDD). Completion of the NDA's submission to the U.S. Food and Drug Administration (FDA) is expected by the end of 2017.

The initiation of the rolling submission for ALKS 5461 is the company's next step in attempting to bring the new medicine to consumers suffering from MDD. ALKS 5461 is a Fast Track  medication, meaning the FDA has designated it to receive a faster review process. Fast Track designation is typically reserved for . . .