RI 002 (formerly Bivigam) establishes a new PDUFA date of 2 April 2019.- ADMA Biologics, Inc
ADMA Biologics, Inc. ,a vertically integrated commercial biopharmaceutical company that develops, manufactures and markets specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (�PIDD�) and the prevention and treatment of certain infectious diseases, announces that the FDA has acknowledged the receipt of ADMA�s September 28, 2018 BLA resubmission for RI-002. (formerly Bivigam). The FDA stated that it considers the RI-002 BLA resubmission �a complete, Class 2 response� and has established an action due date of April 2, 2019, under the Prescription Drug User Fee Act
.Comment: ADMA Biologics obtained ownership and all rights, title and interest in Bivigam on June 6, 2017 as part of the Biotest Therapy Business Unit asset acquisition..