Refusal Reversal: Alkermes Review Back On Track, But Could Still Be Bumpy
US FDA accepts Alkermes' NDA for depression drug after issuing refuse-to-file letter just two weeks ago; unusual move falls outside agency's guidance on RTFs because no changes were made to submission and it wasn't filed over protest.
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US FDA’s decision to issue refuse-to-file action for Alkermes’ buprenorphine/samidorphan combo for major depressive disorder was one of the review issues brought to light by an unusually active advisory committee industry representative.
Nearly every panelist cited lack of substantial evidence of efficacy in voting against approval of ALKS 5461, a fixed-dose combination of buprenorphine and samidorphan.