US generics manufacturer Mylan announced on 19 January 2016 that it had launched a generic version of Meda Pharms’ Felbatol (felbamate) tablets in dosages of 400 and 600 mg in the US.
Mylan launches generic seizure drug in US
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Posted 12/02/2016
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The news comes after Mylan received US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) on 11 January 2016.
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.
According to IMS Health, felbamate tablets in dosages of 400 and 600 mg had US sales of approximately US$53 million for the 12 months ending 30 November 2015.
Other generics of Felbatol are already on the US market. Generic versions by Amneal Pharma and Corepharma were approved by FDA in September 2011 and November 2015, respectively.
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Source: Mylan, US FDA
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