26 July 2018 - Prior approval supplement to amend the biologics license application for Bivigam is supported by data and documentation prepared using ADMA’s optimised IVIG manufacturing process demonstrating robust reproducibility and manufacturing consistency.

ADMA Biologics announces that the U.S. FDA has acknowledged receipt of ADMA’s filing for review which seeks approval to amend the FDA approved application for Bivigam (intravenous immune globulin [human], 10%). 

Once the PAS is approved, ADMA intends to relaunch Bivigam in the U.S. The target action date for the PAS is 25 October 2018 under the Prescription Drug User Fee Act.

Read ADMA Biologics press release