Lincolnshire, Ill., January 16, 2019 — Nexus Pharmaceuticals Inc. announced today the U.S. Food and Drug Administration (FDA) approval of Busulfan Injection, the company’s AP-rated therapeutic equivalent for Busulfex® 60 mg/10 mL (6 mg/1 mL).
“The FDA approval of Busulfan continues to expand our portfolio of difficult to manufacture injectables, in addition to becoming our second oncology generic drug,” said Omair Ahmed, Chief Commercial Officer, Nexus Pharmaceuticals. “Busulfan is currently on American Society of Health System Pharmacists® drug shortage list. The addition of Busulfan will continue to show our commitment to providing patients and clinicians with access to affordable generic alternatives to critical need medicines that have a history of shortage.”
Busulfan is expected to launch in the United States shortly in cartons of eight single-dose vials, each containing 60 mg of busulfan in 10 mL of clear sterile solution. It is Latex and Preservative free.
Busulfan is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
About Nexus Pharmaceuticals Inc.
Nexus Pharmaceuticals Inc., a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.
Nexus Pharmaceuticals Inc.