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zu ADMA - gute nachrichten. ADMA Biologics Announces Commercial Relaunch and its First Commercial Sales of BIVIGAM\u00ae Thu August 22, 2019 7:48 AM|GlobeNewswire|About: ADMA RAMSEY, N.J. and BOCA RATON, Fla., Aug. 22, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures and markets three approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces the commercial relaunch and its first commercial sales of BIVIGAM\u00ae. As previously reported, BIVIGAM\u00ae had a Biologics License Application (“BLA”) manufacturing change Prior Approval Supplement (“PAS”) approved by the United States Food and Drug Administration (“FDA”) on May 9, 2019, enabling ADMA to resume marketing BIVIGAM\u00ae to US- based prescribers and healthcare professionals. BIVIGAM\u00ae is approved for the treatment of patients diagnosed with primary humoral immunodeficiency (“PI”). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (“CVID”), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. “We are very excited to have received the timely FDA PAS approval allowing ADMA to reintroduce BIVIGAM\u00ae to market for PI patients in efforts to address their ongoing medical needs and to address reported US market Intravenous Immune Globulin (“IVIG”) supply constraints. BIVIGAM’s\u00ae relaunch is a result of the culmination of many important milestones, and we are grateful for the efforts of our dedicated staff at ADMA and of the FDA, which have enabled us to bring BIVIGAM\u00ae to market. ADMA looks forward to working with our distribution partner and the physician community as we are prepared and committed to provide a continuous supply of BIVIGAM\u00ae to PI patients,” stated Adam Grossman, President and Chief Executive Officer. https://seekingalpha.com/pr/17610610-adma-biologics-announce… |
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