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Bivigam Approval History

FDA Approved: Yes (First approved December 21, 2012)
Brand name: Bivigam
Generic name: immune globulin intravenous
Dosage form: Infusion
Company: Biotest Pharmaceuticals Corporation
Treatment for: Primary Immunodeficiency Syndrome

Bivigam is an immune globulin intravenous (human) indicated for the treatment of primary humoral immunodeficiency.

Development History and FDA Approval Process for Bivigam

DateArticle
May 10, 2019Approval ADMA Announces It Will Reintroduce Bivigam Into the Market
Dec 21, 2012Approval FDA Approves Biotest's Bivigam, an Intravenous Immune Globulin (Human), 10% Liquid

Further information

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