BRIEF—Nexus Pharma gets FDA approval of busulfan injection

Nexus Pharmaceuticals says that the US Food and Drug Administration has approved busulfan injection, the company's AP-rated therapeutic equivalent for Busulfex 60mg/10mL (6mg/1mL), originated by USA-based PDL BioPharma.

“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 of 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,” he added.

Busulfan is expected to launch in the USA shortly in cartons of eight single-dose vials, each containing 60mg of busulfan in 10mL of clear sterile solution, and 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.