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ADMA Biologics Provides Regulatory Update for BIVIGAM
Oct. 11, 2018 08:59AM PST
Pharmaceutical InvestingADMA 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 it has received a formal communication from the U.S. Food and Drug Administration stating that the FDA considers the Company’s …
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 it has received a formal communication from the U.S. Food and Drug Administration stating that the FDA considers the Company’s recent response to the agency’s information request related to the Prior Approval Supplement (“PAS”) submission a major amendment.
As quoted in the press release:
As a result, the FDA has informed the Company that they require an additional two months to complete their review of the PAS submitted in June 2018 to amend the Biologics License Application (“BLA”) for BIVIGAM®. The FDA has established a target action date of December 18, 2018 for the PAS under the Prescription Drug User Fee Act (“PDUFA”).
This FDA communication received by the Company has no impact on our other ongoing agency interactions or to the recent RI-002 Biologics License Application resubmission.