Dyax Corp. Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema
Published: Jun 08, 2009
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ:DYAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s submission in response to the FDA’s March 2009 Complete Response letter which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax’s BLA a new Prescription Drug User Fee Act (PDUFA) action date of December 1, 2009.