Nexus Pharmaceuticals Inc. announced that 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.