This is the first non-frozen ready-to-use bivalirudin 505b(2) NDA approved by US FDA
Gland Pharma along with its partners MAIA Pharmaceuticals Inc (MAIA) and Athenex Pharmaceutical Division (Athenex) announced the launch of a Ready-to-Use (RTU) Bivalirudin Injection in the US. This is the first non-frozen ready-to-use bivalirudin 505b(2) NDA approved by the US Food and Drug Administration (US FDA).
Bivalirudin RTU 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.
“We are pleased to collaborate with MAIA and Athenex in bringing to market the RTU non-Frozen Version of Bivalirudin Injection. 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, Gland Pharma.
“We are delighted to introduce a unique RTU Bivalirudin Injection that does not require frozen storage into the US hospital market,” said Jeffrey Yordon, Chief Operating Officer Athenex.
Srikanth Sundaram, President, MAIA, added, “Bivalirudin RTU Injection does not need reconstitution and further dilution unlike the lyophilised version, essentially eliminates the drug preparation process. By avoiding potential errors in the drug preparation and administration process and associated adverse events, its use offers benefits to the patient.”
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