Requip gets US FDA "approvable" letter

The US Food and Drug Administration has issued an "approvable" letter for UK drug major GlaxoSmithKline's Requip (ropinerole HCl) extended-release tablet. The letter from the FDA details conditions that must be satisfied prior to obtaining final approval.

Requip XL is a once-daily oral dopamine agonist developed for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The new Requip XL formulation uses London, UK-based SkyePharma's patented Geomatrix technology and is designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. GSK says it will work with the FDA to address any questions the agency has and evaluate the best way forward. The UK firm, which is the world's second-largest R&D-based drugmaker by sales, did not disclose the issues addressed in the letter.

Requip XL is approved in eight countries in Europe and a mutual recognition procedure was successfully completed on November 27, in 17 additional European countries. This step should result in approval of the drug and launches in these countries from the first quarter of 2008 onwards. Last year, sales of Requip, the first-generation, instant-release formulation of the drug, sold as a treatment for PD and restless legs syndrome, grew 7% on the year earlier to L268.0 million ($548.0 million).