Oral Imitrex Approvable In USA

Glaxo has received an approvable letter from the US Food and Drug Administration for the tablet formulation of its antimigraine product Imitrex (sumitriptan succinate).

Approval for the oral form has been delayed for nearly two years, partly due to concerns over possible side effects. Last year, Glaxo had to add a warning to the labelling for the injectable formulation of Imitrex in the USA, following the death of a woman shortly after receiving an injection with the drug. However, Glaxo said that the vast majority of Imitrex users have not suffered side effects, and the few fatalities that have occurred were linked to exceptional circumstances, such as where the patients have been given the drug despite a history of cardiovascular diseases and other risk factors.

In light of these concerns, the FDA has requested that stringent warnings are included on the tablet formulation's labelling.