Lundbeck Inc. Says FDA Accepts Review of Schizophrenia Drug

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 meeting 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.

Back to news