The European Commission, on April 2009, approved a marketing authorization valid throughout the European Union for eslicarbazepine acetate as adjunctive therapy in adult patients with partial-onset seizures with or without secondary generalization; on December 2016, as adjunctive treatment for patients above age six years with partial-onset seizures with or without secondary generalization; and on May 2017, as monotherapy in the treatment of partial-onset seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy.
In the United States, the Food and Drug Administration (FDA), approved eslicarbazepine acetate as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalization on November 2013. On August 2015, FDA approved BIAL's antiepileptic as monotherapy in the U.S., and it can now be used there in people who initiate treatment for the first time or convert from other antiepileptic drugs. In September 2017, the The Food & Drug Administration (FDA) extended the therapeutic indication of eslicarbazepine acetate in the treatment of partial epileptic seizures in children from the age of 4 years.
Opicapone for the treatment of adult Parkinson´s disease patients with motor fluctuations was approved by the European Commission on June 2016. Opicapone is a novel third generation catechol-O-methyltransferase (COMT) inhibitor, providing potent and sustained COMT inhibition. This action enhances the beneficial effects of levodopa in Parkinson’s disease patients with motor fluctuations.
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