Proper Name: Alpha-1-Proteinase Inhibitor (Human)
Manufacturer: Takeda Pharmaceuticals U.S.A., Inc
- Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency).
- September 25, 2023 Approval Letter - GLASSIA
- September 25, 2023 Clinical Memo - GLASSIA
- September 27, 2022 Approval Letter - GLASSIA
- Supporting Documents older than three years - GLASSIA
- Approval History, Letters, Reviews, and Related Documents - GLASSIA
- FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.