Alkermes Advisory Committee Hears More About Refuse-To-File Letter Thanks To Industry Rep
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.
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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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