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# Bio Products Labs Gammaplex 10% Approved
- URL: https://www.fdaweb.com/bio-products-labs-gammaplex-10-approved/
- Published: 2017-02-08T12:00:00.000Z
- Updated: 2026-09-14T22:05:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137936

FDA has approved Bio Products Laboratory’s Gammaplex 10% (immune globulin intravenous \[human\], 10% liquid) for treating primary immunodeficiency (PI) and chronic immune thrombocytopenic purpura in adults. Gammaplex 10% is made with the same process as the company’s previously approved Gammaplex 5%. The latest product, Bio Products says, is more concentrated than the previous product, with an immune globulin G concentration of 100g/L, and is stabilized with glycine. 

The approval was based on a two-phase, crossover bioequivalence study comparing Gammaplex 10% and Gammaplex 5% in 33 adult patients with PI. “The primary endpoint of bioequivalence between the products was achieved and trough levels of IgG were well maintained throughout the study, the company says.