Otsuka seeks to block Alkermes' Abilify formulation

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) filed a Citizen's Petition with FDA asking the agency to deny or delay approval of an NDA for aripiprazole lauroxil from Alkermes plc (NASDAQ:ALKS) to treat schizophrenia. The NDA has an Aug. 22 PDUFA date.

Otsuka and partner H. Lundbeck A/S (CSE:LUN) market a once-monthly intramuscular formulation of aripiprazole as Abilify Maintena in the U.S. and EU. Alkermes' candidate is an extended-release, once-monthly, injectable formulation of aripiprazole that uses the company's LinkeRx technology. ...