In reversal, FDA accepts Alkermes ’ depression drug for review

In an about-face, the FDA reportedly agreed to review a new drug application for Alkermes‘ (NSDQ:ALKS) depression drug just weeks after the agency said it would only do so if the company conducted additional trials. Alkermes’ once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with major depressive disorder for whom standard antidepressant therapies have not worked. Get the full story at our sister site, Drug Delivery Business News. The post In reversal, FDA accepts Alkermes’ depression drug for review appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Neurological Pharmaceuticals Regulatory/Compliance Wall Street Beat alkermes Source Type: news