Breaking News, Trials & Filings

FDA Assigns PDUFA Date to Portola Pharmaceuticals

For the large-scale Generation 2 manufacturing process for Andexxa

Portola Pharmaceuticals announced that the U.S. Food and Drug Administration has acknowledged receipt of the Company’s Prior Approval Supplement (PAS) filing for the large-scale Generation 2 manufacturing process for Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo].    The PAS has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 31, 2018. If accepted and approved, the PAS will allow for the broad commercial launch of Andexxa in the United States. ...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters