Less than a month after the FDA refused to review Alkermes’ new drug application for the company’s depression drug, the agency has changed its mind, according to a statement from the company. After it “clarified certain aspects of the NDA submission”, Alkermes said Monday that the FDA will now accept the application without requiring additional data or analyses.
It’s quite an about-face. According to the company, FDA officials said in a March 30 letter that Alkermes (NASDAQ: ALKS) had provided insufficient evidence of overall effectiveness of the drug, ALKS 5461, and that they required more clinical trials and an… Read more »
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