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Glassia FDA Approval History

FDA Approved: Yes (First approved July 1, 2010)
Trade names: Glassia
Generic name: alpha1-proteinase inhibitor (human)
Routes of administration‎: Injection
Previous Name: AAT-IV
Company: Kamada Ltd.
Target disease‎: Alpha-1 Proteinase Inhibitor Deficiency
Pregnancy Category: US: ‎B (No risks have been found in humans.)
ATC code‎: B02AB02

Glassia is an alpha1-proteinase inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1antitrypsin deficiency.

Development timeline for Glassia

Jul  6, 2010Approval Kamada Wins FDA Approval for Glassia - a New Liquid, Ready-to-Use Treatment for Alpha-1 Antitrypsin Deficiency
Aug  4, 2009Kamada's Biologics License Application for IV-AAT to Treat Alpha-1 Antitrypsin Deficiency is Accepted for Review by the US Food and Drug Administration
Jun  2, 2009Kamada Submits U.S. Biologics License Application for the First Liquid, Ready to Use AAT for the Treatment of Alpha-1 Antitrypsin Deficiency

Further information

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