RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a new indication for an epilepsy drug made by GlaxoSmithKline, the drug maker said Monday.
GSK announced the approval of Lamictal XR (lamotrigine) extended-release tablets as a single-drug therapy, also known as a monotherapy, in epileptic patients ages 13 years and older with partial-onset seizures already taking a single drug and interested in switching over. However, the company said the safety of starting off with Lamictal XR as a monotherapy or switching to the drug as a monotherapy after taking two or more anti-epileptic drugs had not been established. The drug already is approved as an add-on treatment.
“We are committed to providing new and effective treatment options for patients,” GSK SVP neurosciences medicines development center Atul Pande said.