ADMA Biologics provides regulatory update on Bivigam PAS submission
ADMA Biologics announced that the FDA has issued a Complete Response Letter for the drug substance Prior Approval Supplement submission and previously approved the drug product PAS submission. The FDA approved ADMA's drug product PAS submission which was comprised of fill, finish and final release information of the drug product. The FDA issued a CRL to ADMA pertaining to only the drug substance PAS submission which pertains to chemistry, manufacturing and controls information. In the CRL, the FDA did not request any information pertaining to compliance status, clinical study safety and efficacy. The company believes the FDA comments to the drug substance PAS submission are "addressable and resolvable". The company will request a meeting with the FDA to provide the FDA with clarification and responses to the issues raised in the CRL.