FDA Approves BW's Lamictal

Wellcome's US subsidiary, Burroughs Wellcome, has received approval from the US Food and Drug Administration to market Lamictal (lamotrigine), its new anticonvulsant agent. It is indicated as an add-on therapy in adult patients who experience partial seizures which are not effectively controlled with first-line medication.

Lamotrigine has now been approved in 46 countries as a second-line therapy, and submissions have been made in 18 countries for monotherapy use. Clinical trials have shown that lamotrigine can achieve an improvement in 65% of patients whose symptoms are not controlled by their current medication. In about 25% of these patients, seizure frequency was reduced by more than 50%. A useful characteristic of the drug is its low rate of interactions with other anticonvulsants, allowing it to be added to existing regimens safely.

...And Navelbine The FDA has also approved Navelbine (vinorelbine tartrate), an anticancer agent for the treatment of ambulatory patients with advanced, unresectable non-small cell lung cancer. It becomes the first new drug licensed for this disease in the USA for 20 years. The drug will be marketed in the USA by BW, but was originally developed by Pierre Fabre of France. Navelbine is approved in the USA for single-agent use to treat patients with Stage IV NSCLC, and with cisplatin for treating Stage III or Stage IV disease.