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ARTICLE | Clinical News

FDA panel to discuss Alkermes' depression candidate

September 21, 2018 6:26 PM UTC

FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will meet Nov. 1 to discuss an NDA from Alkermes plc (NASDAQ:ALKS) for ALKS 5461 as an adjunct to treat major depressive disorder. The PDUFA date is Jan. 31, 2019.

In April, FDA reversed its decision to refuse to file the application (see "FDA Accepts NDA for Alkermes' Depression Candidate, Reversing Refusal")...

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