Mylan N.V., a global pharmaceutical company, announced the US launch of fosphenytoin sodium injection USP, 75 mg/mL, (50 mg PE/mL), packaged in 100 mg PE/2 mL, and 500 mg PE/10 mL single-use vials, a generic version of Pfizer's Cerebyx injection.

Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, for the treatment of certain types of severe seizures.

Fosphenytoin sodium injection USP, 75 mg/mL, (50 mg PE/mL), packaged in 100 mg PE/2 mL, and 500 mg PE/10 mL single-use vials had US sales of approximately $36.3 million for the 12 months ending October 31, 2016, according to IMS Health.

The product is part of Mylan's growing global portfolio of more than 450 injectable products, which includes liquid, lyophilized and dry-powder formulations delivered in a range of mechanisms including ampoules, vials, ready-to-use bags and pre-filled syringes. Mylan's global network of nine injectable facilities produces hundreds of millions of doses each year.

Currently, Mylan has more than 240 ANDAs pending FDA approval representing approximately $95.6 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $32.5 billion in annual brand sales, for the 12 months ending June 30, 2016, according to IMS Health.