Gland Pharma Ltd, along with its partners MAIA Pharmaceuticals Inc (MAIA) and Athenex Pharmaceutical Division (Athenex) has launched a Ready-to-Use (RTU) Bivalirudin Injection in the United States of America (USA).
“This is the first non-frozen ready-to-use bivalirudin 505b(2) NDA approved by the US Food and Drug Administration (USFDA),’’ the Hyderabad-based company said in a release.
The Bivalirudin RTU Injection is meant to be used as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
“We believe that this complements our commitment to provide Easy to Use, Safe to Deliver, Cost Effective Products to clinicians,” said Srinivas Sadu, MD and CEO of Gland Pharma.