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Alpha-1 Proteinase Inhibitor Deficiency Blog
Kamada Wins FDA Approval for Glassia - a New Liquid, Ready-to-Use Treatment for Alpha-1 Antitrypsin Deficiency
Posted 7 Jul 2010 by Drugs.com
NESS ZIONA, Israel--(BUSINESS WIRE)--Jul 6, 2010 - Kamada today announced that the United States Food and Drug Administration (FDA) has approved Glassia (Alpha 1 Proteinase inhibitor, also known as Alpha-1-Antitrypsin (AAT) for the treatment of Alpha 1 deficiency (AATD). Glassia is now the first and only liquid Alpha- 1-Proteinase Inhibitor worldwide available liquid, ready to use, Alpha- 1-Proteinase Inhibitor on the market. The FDA approved Glassia following review of Kamada's Biological License Application (BLA) submitted in May 2009. The FDA's review included Kamada's clinical development as well as auditing and approving Kamada's manufacturing facility, quality assurance and controls. David Tsur, Chief Executive Officer of Kamada said, "We are very proud with this achievement. This success belongs to each one of the company's employees. With this unique product, Kamada is able to ... Read more