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Alkermes Gains NDA Acceptance for MDD Treatment That was Previously Rejected by the FDA

20:00 EDT 15 Apr 2018 | BioSpace

In a stunning about-face the U.S. Food and Drug Administration (FDA) has accepted Alkermes New Drug Application for ALKS 5461. The FDA rejected the NDA at the end of March over a lack of data.

Original Article: Alkermes Gains NDA Acceptance for MDD Treatment That was Previously Rejected by the FDA

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