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Gland Pharma, Partners MAIA, Athenex Launch Anticoagulant Injection in USA

For representational purpose only. (Image: REUTERS)

For representational purpose only. (Image: REUTERS)

This is the first on-frozen ready-to-use bivalirudin 505b(2) NDA approved by the US Food and Drug Administration (USFDA), a press release from Gland Pharma said.

Gland Pharma Ltd along with its partners MAIA Pharmaceuticals Inc and Athenex Pharmaceutical Division on Monday announced the launch of a Ready-to-Use Bivalirudin Injection in the US.

This is the first on-frozen ready-to-use bivalirudin 505b(2) NDA approved by the US Food and Drug Administration (USFDA), a press release from Gland Pharma said.

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," Srinivas Sadu, MD and CEO of Gland Pharma said.

"We are delighted to introduce a unique RTU Bivalirudin Injection that does not require frozen storage into the US hospital market," Jeffrey Yordon, Athenex's Chief Operating Officer said.

Bivalirudin RTU Injection does not need reconstitution and further dilution unlike the lyophilized 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, Srikanth Sundaram, President of MAIA added.