ADMA Biologics Says Its ASCENIV And BIVIGAM Get FDA Approval For Extended Shelf Life

(RTTNews) - ADMA Biologics, Inc. (ADMA) on Friday announced FDA approval for extended shelf life for its ASCENIV and BIVIGAM to 36 months from 24 months.

The expiration date extension applies to existing lots, as well as future production in all vial sizes, production scales, as well as internal and external fill-finishing for both ASCENIV and BIVIGAM stored at 2-8°C, ADMA noted.

Extended shelf life ASCENIV & BIVIGAM are currently available in the U.S.

"The approval represents an important milestone as it pertains to the culmination of remediation initiatives enacted since ADMA acquired the Boca Raton, FL manufacturing facility in 2017. We believe this FDA approval of shelf-life extension clearly demonstrates ADMA's IG portfolio and production processes are of a high-quality and meet all requirements for stability in the eyes of regulators," said Adam Grossman, President and Chief Executive Officer of ADMA.