FDA Denial Of Otsuka’s Citizen’s Petition Opposing Approval Of Aripiprazole Formulation Aristada As Competitor To Abilify Maintena

This document was released on October 5, 2015 by the U.S. Food and Drug Administration to Otsuka Pharmaceutical Development and Commercialization, Inc. This letter responds to the citizen petition dated July 13, 2015 (Petition or Otsuka Petition), submitted on behalf of Otsuka Pharmaceutical Development & Commercialization, Inc. and on behalf of its parent company, Otsuka Pharmaceuticals Co., Ltd., and its affiliates (collectively Otsuka). The Petition requests that the Food and Drug Administration (FDA or Agency) refuse to approve or delay approval of the new drug application (NDA) submitted by Alkermes Inc. (Alkermes) for Aristada (aripiprazole lauroxil) extended-release injectable suspension . . .