The FDA has approved GlaxoSmithKline’s Lamictal XR extended-release tablets as once-a-day, add-on therapy for epilepsy in patients over 13 years of age suffering from primary generalized tonic-clonic seizures. Lamictal XR is already approved for partial onset seizures for patients in this age group.

The study depicted that the addition of Lamictal XR in therapy reduced the seizure frequency more than placebo in patients with uncontrolled primary generalized tonic-clonic seizures.

Lundbeck Inc has received approval from the FDA for its two New Drug Applications (NDA), Sabril (vigabatrin) Tablets and Oral Solution. Lundbeck will be launching Sabril in the US during the third quarter. Sabril is indicated as a monotherapy for pediatric patients, aged between one month and two years, with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss. The drug is also indicated as an add-on therapy for adult patients with refractory complex partial seizures who have failed other available treatments and for whom the potential benefits outweigh the risk of vision loss.