CORRECTED-Lundbeck says FDA accepts review of schizophrenia drug

Wed Sep 12, 2012 11:17pm IST



(Corrects 2nd paragraph to say Feb. 28 is FDA decision deadline, not a meeting)

COPENHAGEN, Sept 12 (Reuters) - Danish pharmaceutical group Lundbeck said the U.S. Food and Drug Administration was to review a resubmission of a new drug application for treating schizophrenia.

A new FDA deadline to make a decision regarding the treatment, aripiprazole depot formulation, had been set for Feb. 28, Lundbeck said on Wednesday in a statement with Japanese firm Otsuka Pharmaceutical Co with whom it is in partnership, following initial deficiencies in the application.

Lundbeck has co-development and co-commercialisation rights to aripiprazole depot formulation in North and Latin America as well as Europe, Australia and some other countries.

(Reporting by Copenhagen Newsroom; Editing by Dan Lalor and Gerald E. McCormick)