Product Approval Information
Proper Name: Alpha-1-Proteinase Inhibitor (Human)
Tradename: Aralast
Manufacturer: Baxter Healthcare Corp, License #0140
Package Insert - December, 2002
Date: December 23, 2002
Indication: For augmentation therapy in patients having congenital deficiency of alpha-1-proteinase inhibitor with clinically evident emphysema
March 21, 2003 (Corrected) Approval Letter
Summary Basis of Approval
Appendix
Date: September 9, 2005 (corrected letter issued 9/22/2005)
Manufacturing Change Fr.IV1+4 paste as an alternate starting material
September 22, 2005 Corrected Approval Letter