Alkermes, Otsuka Pharmaceutical sales and marketing update

Otsuka filed a Citizen’s Petition with FDA asking the agency to deny or delay approval of an NDA for aripiprazole lauroxil from Alkermes to treat schizophrenia. The NDA has an Aug. 22 PDUFA date.

Otsuka and partner H. Lundbeck A/S (CSE:LUN, Cophenhagen, Denmark) 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. ...