FDA accepts Vanda Pharmaceuticals Iloperidone resubmission

Nov 20 2008

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, reported today that the FDA has accepted Vanda's resubmission of the iloperidone New Drug Application (NDA).

Vanda's resubmission was a Complete Response to the not approvable action letter that the company received on July 25, 2008. The FDA has indicated that it has accepted the Complete Response for review and has set a new target action date of May 6, 2009.

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders.http://www.vandapharma.com/