FDA declines to approve Alkermes opioid-based depression drug - Southern Business Review

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Friday, February 1, 2019

FDA declines to approve Alkermes opioid-based depression drug

(Reuters) - The U.S. Food and Drug Administration on Friday declined to approve Alkermes Plc’s opioid-based depression treatment, citing the need for additional data to prove the effectiveness of the drug.


The largely expected decision comes months after an advisory panel to the FDA strongly voted against the drug and raised questions on its safety and efficacy.




Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Arun Koyyur