Mylan launches generic Felbatol tablets in USA

21 January 2016

Netherlands-incorporated Mylan (Nasdaq: MYL) has announced the US launch of felbamate tablets USP, 400mg and 600mg, which is the generic version of Swedish drugmaker Meda Pharma’s (OMX: MEDA A) Felbatol Tablets.

Mylan, whose shares rose 2.35% to $51.40 in a declining US market yesterday, received final approval from the US Food and Drug Administration 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, 400mg and 600mg, had US sales of around $53 million for the 12 months ending November 30, 2015, according to IMS Health data quoted by Mylan.

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