Edition:
India

ADMA Biologics Receives PDUFA Date For Bivigam Regulatory Submission


Thursday, 26 Jul 2018 

July 26 (Reuters) - ADMA Biologics Inc ::ADMA BIOLOGICS RECEIVES PDUFA DATE FOR BIVIGAM REGULATORY SUBMISSION.ADMA BIOLOGICS INC - ONCE PAS IS APPROVED, ADMA INTENDS TO RELAUNCH BIVIGAM IN U.S.ADMA BIOLOGICS INC - TARGET ACTION DATE FOR PAS IS OCTOBER 25, 2018 UNDER PRESCRIPTION DRUG USER FEE ACT.ADMA BIOLOGICS - ANTICIPATES RELAUNCHING BIVIGAM, UTILIZING 3 PRODUCED CONFORMANCE LOTS TO GENERATE ACCRETIVE REVENUE IN ADVANCE OF/DURING Q1 2019.