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FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date Print E-mail
19 Nov 2008

Vanda Pharmaceuticals reported today that the FDA has accepted Vanda's resubmission of the iloperidone New Drug Application (NDA)

ROCKVILLE, MD, USA | November 20, 2008 | Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), 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.

ABOUT VANDA PHARMACEUTICALS INC.:

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

SOURCE Vanda Pharmaceuticals Inc.





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