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FDA Reversal Puts Alkermes Depression Drug Back On Track For January Approval

 
• By Jessica Merrill

Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.

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Alkermes PLC investors woke up to a pleasant surprise April 16 with news the US FDA has accepted a new drug application (NDA) for the company's depression drug candidate ALKS 5461, reversing an earlier refuse-to-file (RTF) action. FDA's change of heart was made quickly enough to keep the application on the original user fee time clock of Jan. 31, 2019 set by the original submission.

Such a quick reversal is unusual for FDA, particularly for an RTF, which generally suggests something is fundamentally missing from the submission. In this case the RTF, announced April 2,...

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