FDA Delays Approval Of First Agent To Reverse Effect Of New Anticoagulants

  Portola Pharmaceuticals announced late on Wednesday evening that it had received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). Approval for the drug had been widely expected earlier in the day, which was the drug’s PDUFA date. The drug had been on an accelerated...Click here to continue reading...

Source: CardioBrief - August 18, 2016 Category: Cardiology Authors: Larry Husten Tags: Heart Rhythms Interventional Cardiology & Surgery andexanet anticoagulants CRL FDA Portola reversal agent Source Type: blogs