There is on-going development of generic EU CTD Dossier of Oxcarbazepine, filmcoated tablets, 150/300/600 mg.
Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.
Oxcarbazepine is an anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy. It is also used to treat anxiety and mood disorders, and benign motor tics. Oxcarbazepine is marketed as Trileptal by Novartis and in Egypt is marketed also as Oxaleptal 600mg by Mash Premiere and available in some countries as a generic drug.
Oxcarbazepine is a structural derivative of carbamazepine, with a ketone in place of the carbon-carbon double bond on the dibenzazepine ring. This difference helps reduce the impact on the liver of metabolizing the drug, and also prevents the serious forms of anemia or agranulocytosis occasionally associated with carbamazepine. Aside from this reduction in side effects, it is thought to have the same mechanism as carbamazepine - sodium channel inhibition (presumed to be the main mechanism of action) - and is generally used to treat the same conditions. Oxcarbazepine has recently been found to be associated with a greater enhancement in mood and reduction in anxiety symptoms than other drugs employed to treat epilepsy.
More details at: http://www.rxlist.com/trileptal-drug.htm.
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