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Mylan, Aspen introduce generic Busulfex injection in US market

Hertfordshire, England
Tuesday, December 5, 2017, 18:00 Hrs  [IST]

Mylan N.V. and its partner, Aspen announced the US 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 US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, 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 Busulfan injection, 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 Busulfan injection, 60 mg/10 mL (6 mg/mL) single-dose vial were approximately $97 million for the 12 months ending Sept. 30, 2017, according to IQVIA.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare.

Aspen is a leading global player in specialty, branded and generic pharmaceuticals with an extensive basket of products that provide treatment for a broad spectrum of acute and chronic conditions experienced through all stages of life.


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