Mylan N.V. today announced the U.S. 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 U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for the product, which is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Dose Vials had U.S. sales of approximately $53 million for the 12 months ending Sept. 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 Aug. 31, 2017, according to IQVIA. Currently, one out of every 13 prescriptions filled in the U.S. — brand-name or generic — is a Mylan product.
Mylan offers more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40 percent of people being treated for HIV/AIDS globally depend.
