FDA "approvable" for GSK's Requip CR

GlaxoSmithKline, the word second-largest drugmaker, has received an "approvable" letter from the US Food and drug administration for its Requip CR (ropinerole HCl) extended-release tablets for the treatment of moderate-to-severe primary restless legs syndrome.

This is a notification of conditions that must be satisfied before the regulator clears the tablets for sale. GSK did not reveal what additional information the FDA requires, but says it is working with the agency to address these issues, and stresses that the existing, approved, Requip formulation is not affected by the decision.