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Mylan/Aspen launch generic busulfan injection Posted 08/12/2017

US generics giant Mylan Pharmaceuticals (Mylan) and its partner, generics manufacturer Aspen Pharmacare Holdings (Aspen), announced on 4 December 2017 that it had launched generic Myleran (busulfan) single-dose vial in the US, after receiving final approval from the US Food and Drug Administration (FDA).

Myleran is a generic version of Otsuka Pharmaceutical’s Busulfex Injection, which is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic haematopoietic progenitor cell transplantation for chronic myelogenous leukaemia.

As part of its partnership with Aspen, Mylan will commercialize Myleran, 60 mg/10 mL (6 mg/mL) single-dose vial in the US. Mylan has one of the largest injectable portfolios in the industry and is also one of the largest suppliers of cancer medicines by volume in the US.

US sales for Busulfex Injection, 60 mg/10 mL (6 mg/mL) single-dose vial were approximately US$97 million for the 12 months ending 30 September 2017, according to IQVIA.

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Source: Mylan

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