BioMarin Announces That FDA Has Advised it Will Not Take Action on the Kyndrisa™ (dris­apersen) New Drug Application by the PDUFA Date

SAN RAFAEL, Calif., Dec. 18, 2015 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the U.S. Food and Drug Administration (FDA) has noti­fied the Company that they had not yet com­plet­ed their review process and would be unable to take an action by the Prescription Drug User Fee Act (PDUFA) action date for KyndrisaTM (dris­apersen) of December 27, 2015, and antic­i­pate tak­ing action in ear­ly January 2016.

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