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Two weeks ago, it looked like the hopes for Alkermes’ ALKS 5461 receiving approval would rely on returning to the clinic to undergo the lengthy process of gathering more data on the drug, after it received a Refuse to File letter from the FDA.
Now, the agency has switched up its position, catching everyone off guard with its decision to accept for review Alkermes’ NDA for ALKS 5461.
As the FDA is not compelled to provide a reason for this about-face, the only information coming out of the decision is from Alkermes.
Original Article: FDA flip-flops on Alkermes' drug applicationNEXT ARTICLE
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