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Recognize 5-year Exclusivity for Each of The New Active Moieties in Stribild, Namely EVG and COBI and Make any Necessary Changes to FDA's Exclusivity Summary to Reflect an Interpretation of the Governing Statute and Regulation that Recognizes 5-year Exclusivity for all Active Moieties - CLOSED

Abstract: Reopened on 03/25/2014
Type: Non-Rule Making
Docket Item Code P
Center CDER