Mylan To Commercialize Generic Busulfex Injection In U.S. - Quick Facts

(RTTNews) - Mylan N.V. (MYL) announced that the company and its partner, Aspen announced the U.S. launch of Myleran (busulfan) Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial, a generic version of Otsuka Pharmaceutical's Busulfex Injection. Aspen received final approval from the U.S. FDA for its Abbreviated New Drug Application for the product.

Myleran is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. Mylan will commercialize Busulfan Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial in the U.S.