Mumbai, June 08, 2020: Gland Pharma Ltd. (Gland Pharma), along with its partners MAIA Pharmaceuticals, Inc. (MAIA) and Athenex Pharmaceutical Division (Athenex) announce the launch of a Ready-to-Use (RTU) Bivalirudin Injection in the United States of America. This is the first non-frozen ready-to-use bivalirudin 505b(2) NDA approved by the U.S. Food and Drug Administration (USFDA).
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 of 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, Athenex’s Chief Operating Officer.
Srikanth Sundaram, Ph.D., President of MAIA, added, “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.”
Corporate Comm India (CCI Newswire)
New Delhi, May 17, 2024: In response to the growing need for specialized pediatric care,…
Achieves significant advancement in Cancer Treatment to Enhance Quality of Life As per the National…
-An 11-year-old boy from Yemen and a 34-year-old man from Bengaluru, both suffered from end-stage…
Mumbai, 14th May 2024 – As part of its dedication to exceptional patient care, American Oncology…
Mumbai, May 11, 2024: In a landmark move for Indian healthcare, the introduction of Second…
Bengaluru, May 08, 2024: Cancer remains the illness most feared across the globe. But to combat…