Nexus Pharmaceuticals announces FDA approval of Busulfan Injection

On January 16, 2019 Nexus Pharmaceuticals Inc. reported 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) (Press release, Nexus Pharma, JAN 16, 2019, View Source [SID1234532683]).

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"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.

About Busulfan Injection

Busulfan is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.