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Flamel Technologies SA Announces Acceptance Of FDA Review For Second NDA

Wednesday, 11 Sep 2013 08:00am EDT 

Flamel Technologies SA announced that US Food and Drug Administration (FDA) has accepted for review the Company's second new drug application (NDA). Flamel has received a Prescription Drug User Fee Act (PDUFA) date, the target date for the FDA to complete its review of the NDA, of April 28, 2013. For competitive reasons, the Company has decided not to identify the product at this time, but intends to provide additional information at a later date. 

Company Quote

-0.32 -2.46%
22 Oct 2014