NEW YORK (Reuters) - U.S. regulators have concluded that GlaxoSmithKline’s (GSK.L) Requip CR extended-release tablets to treat moderate-to-severe primary restless legs syndrome must meet additional conditions before getting final approval, the company said on Friday.
Glaxo said the U.S. Food and Drug Administration granted an “approvable letter” for the tablets -- a notification of conditions that must be satisfied before the regulator clears the tablets for sale.
The company said it is committed to working with the FDA to address questions it may have. Glaxo did not immediately return a call seeking comment on what those questions are.
Glaxo said the decision does not affect the current formulation of Requip tablets to treat the condition.