For heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis…. NDA 211215, held by Maia Pharms Inc. Bivalirudin.
As of Nov 14, 2026, NDA 211215 (Angiomax Rtu), held by Maia Pharms Inc, was first approved by FDA on Jul 25, 2019, with 1 approved supplement and 0 published complete response letters.
Bivalirudin Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Angiomax Rtu250MG/50ML (5MG/ML) · solution;intravenous | Bivalirudin | RxReference drug |
| May 9, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Jul 25, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
