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CORRECTED-Lundbeck says FDA accepts review of schizophrenia drug
September 12, 2012 / 5:37 AM / 5 years ago

CORRECTED-Lundbeck says FDA accepts review of schizophrenia drug

(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

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