FDA Approves Generics for Treatment of Restless Legs Syndrome

By Peggy Peck
ROCKVILLE, 13 may 2008 -- The FDA has given the go-ahead to four companies to produce generic versions of ropinirole hydrochloride (Requip) for treatment of moderate to severe restless legs syndrome.
Roxane Laboratories, in Columbus, Ohio; Teva Pharmaceuticals USA, in North Wales, Pa.; Par Pharmaceuticals, in Woodcliff Lake, N.J.; and Mylan Pharmaceuticals in Morgantown, W.Va., all received permission to make generic versions of the drug in 0.25 mg., 0.5 mg., 1 mg., 2 mg., 3 mg., and 4 mg. doses.
The FDA said, however, that the generic version was approved only for restless legs syndrome, not for treatment of Parkinsonian symptoms, an indication for the brand name drug.
GlaxoSmithKline still has a month remaining on its patent protection for treatment of Parkinson's disease, but the FDA said that makers of the generics can apply for Parkinson's labeling when that protection expires.
The generic ropinirole hydrochloride tablets will have the same safety warnings as the brand name drug including warnings about patient reports of falling asleep -- sometimes with no warning feelings of sleepiness -- while engaged in activities of daily living, including while driving.
Some of these events have been reported as late as a year after the patient started treatment.