Lundbeck: FDA accepts review of schizophrenia drug

Posted by herpills on September 13, 2012, at 14:11:34

(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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