Novartis' Trileptal cleared in EU

Novartis says it has been granted a pan-European marketing license forits antiepileptic drug Trileptal (oxcarbazepine). The drug was cleared earlier this year in Denmark, which acted as the rapporteur state for European Union approval under the mutual recognition procedure. Trileptal will be indicated for partial seizures with or without secondarily generalized tonic-clonic seizures as a monotherapy and adjunctive therapy in children and adults.

Novartis also recently received an approvable letter from the US Food and Drug Administration for Trileptal tablets (Marketletter October 4). While it is marketed in more than 30 countries, Trileptal has been revamped by Novartis, which filed a new global dossier for the drug in 1998 emphasizing its utility as a first-line drug with good tolerability that can be used as a monotherapy.

- Meantime, Novartis' angiotensin II receptor antagonist Diovan (valsartan) has been approved for marketing in China, reports Chinese Medical News.