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# Nexus Pharma’s Generic Busulfex Approved
- URL: https://www.fdaweb.com/nexus-pharmas-generic-busulfex-approved/
- Published: 2019-01-17T12:00:00.000Z
- Updated: 2026-09-15T00:55:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143174

FDA has approved a Nexus Pharmaceuticals ANDA for busulfan injection, the company’s AP-rated therapeutic equivalent to Otsuka’s Busulfex 60 mg/10 mL (6 mg/1 mL). “Busulfan is currently on the [American Society of Health System Pharmacists](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.ashp.org%2FDrug-Shortages%2FCurrent-Shortages%2FDrug-Shortage-Detail.aspx%3Fid%3D509&esheet=51927098&newsitemid=20190116005876&lan=en-US&anchor=American+Society+of+Health+System+Pharmacists%C2%AE&index=1&md5=7faa25d22ef2ab16509626f84f5ca6dc&ref=fdaweb.com) drug shortage list,” Nexus notes. It is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.