Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Felbamate Tablets USP, 400 mg and 600 mg, which is the generic version of Meda Pharms' Felbatol® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Felbamate Tablets are recommended for monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
Felbamate Tablets USP, 400 mg and 600 mg, had U.S. sales of approximately $53 million for the 12 months ending Nov. 30, 2015, according to IMS Health.
Currently, Mylan has 269 ANDAs pending FDA approval representing $101.5 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $35.6 billion in annual brand sales, for the 12 months ending June 30, 2015, according to IMS Health.