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Mylan introduces generic Clolar for injection in US market

Hertfordshire, England
Friday, November 10, 2017, 16:00 Hrs  [IST]

Mylan N.V.,a global pharmaceutical company, announced the US launch of clofarabine injection, 20 mg/20 mL (1 mg/mL) single-dose vials, a generic version of Genzyme's Clolar.

Mylan 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 the treatment of paediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukaemia after at least two prior regimens.

Mylan is one of the largest suppliers of cancer medicines by volume in the US, with a robust oncology portfolio of more than 40 products.

Clofarabine injection, 20 mg/20 mL (1 mg/mL) single-dose vials had US sales of approximately $53 million for the 12 months ending September 30, 2017, according to IQVIA.

Currently, Mylan has 219 ANDAs pending FDA approval, representing approximately $93.5 billion in annual brand sales. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $42.1 billion in annual brand sales, for the 12 months ending August 31, 2017, according to IQVIA.


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