Nexus Pharmaceuticals gets FDA OK for generic Busulfex injection
Nexus Pharmaceuticals' latest Food and Drug Administration-approved generic is growing its oncology portfolio. The agency has given its blessing for the Lincolnshire, Ill.-based company's generic Busulfex.
The generic Busulfex (busulfan) 6 mg/1 ml is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
“The FDA approval of busulfan continues to expand our portfolio of difficult to manufacture injectables, in addition to becoming our second oncology generic drug,” Nexus Pharmaceuticals chief commercial officer Omair Ahmed said. “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.”
Nexus' generic Busulfex will be available in cartons of eight single-dose vials, each containing 60 mg of busulfan in 10 ml of clear sterile solution.
The generic Busulfex (busulfan) 6 mg/1 ml is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
“The FDA approval of busulfan continues to expand our portfolio of difficult to manufacture injectables, in addition to becoming our second oncology generic drug,” Nexus Pharmaceuticals chief commercial officer Omair Ahmed said. “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.”
Nexus' generic Busulfex will be available in cartons of eight single-dose vials, each containing 60 mg of busulfan in 10 ml of clear sterile solution.