ARTICLE | Company News
FDA wants more data for Alkermes' depression therapy
February 1, 2019 9:36 PM UTC
Alkermes plc (NASDAQ:ALKS) said FDA issued a complete response letter for its NDA for ALKS 5461 as an adjunct treatment of major depressive disorder.
The company said the agency is requesting additional clinical data showing "substantial evidence of effectiveness" to support approval of the fixed-dose combination of buprenorphine and samidorphan...
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