LONDON GlaxoSmithKline has failed to gain approval from the Food and Drug Administration for an extended release version of its epilepsy drug Lamictal, according to Bloomberg.com.
The FDA has requested additional analyses of previously submitted data, and not more studies, said holly Russell, a spokeswoman for GlaxoSmithKline. Teva has an agreement with the company to start marketing a generic version of the standard release version of Lamictal in 2008. The longer lasting version of the drug was planned as a way of easing the company’s future of facing generic competition.
Lamictal had sales of $1.8 billion in 2006.