October 03, 2006
Product news from the 10/03/06 News Brief
The FDA granted expanded indication to GlaxoSmithKline’s anti-seizure medicine Lamictal (lamotrigine) for treatment of Primary Generalized Tonic-Clonic (PGTC) seizures, also known as "grand mal" seizures, in children aged 2 and older and adults. Axcan Pharma said the FDA has issued an approval letter for the company's New Drug Application for Pylera (formerly Helizide). Pylera is a patented 3-in-1 capsule triple therapy, for the eradication of Helicobacter pylori, a bacterium recognized as being the main cause of gastric and duodenal ulcers. Gilead Sciences has agreed to acquire Myogen in a deal worth approximately $2.5 billion. The deal means that Gilead will acquire Myogen's main drug candidate, Ambrisentan, a pulmonary arterial hypertension treatment in late-stage clinical trials.