ADMA Biologics Provides Regulatory Update on BIVIGAM PAS Submissions

ADMA Biologics (NASDAQ:ADMA) a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration has issued a Complete Response Letter for the drug substance Prior Approval Supplement submission and previously approved the drug product PAS submission.

As quoted in the press release:

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 nor any information requests regarding third party contract manufacturers and vendors. The CRL did not contain any requests for additional manufacturing runs. 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 and plans to promptly provide the FDA with clarification and responses to the issues raised in the CRL. The Company looks forward to working with the FDA to resolve the outstanding issues identified in the CRL.

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