(Corrects 2nd paragraph to say Feb. 28 is FDA decision
deadline, not a meeting)
COPENHAGEN, Sept 12 Danish pharmaceutical group
Lundbeck said the U.S. Food and Drug Administration was
to review a resubmission of a new drug application for treating
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)