Court Lets Alkermes Intervene in Aristada Approval Suit

Alkermes Plc won its motion to intervene in Otsuka Pharmaceutical Co.'s suit against the FDA seeking to overturn the agency’s approval of Alkermes’s Aristada, an extended-release injectable schizophrenia drug (Otsuka Pharmaceutical Co. v. Burwellorder granting motion to intervene).

Japan-based Otsuka, the maker of the blockbuster schizophrenia treatment Abilify (aripiprazole), sued the agency in the U.S. District Court for the District of Columbia Oct. 15, alleging that the FDA’s approval of Aristada (aripiprazole lauroxil), a competitor to Otsuka’s Abilify, is arbitrary, capricious, and unlawful 13 PLIR 1509, 10/23/15. Otsuka seeks to block the agency from approving Aristada until ...