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Posted: May 28, 2008

FDA Approves Generic Drug for Restless Legs Syndrome

The Food and Drug Administration says a popular drug in the treatment of Parkinson’s disease has been approved as the first generic version of a drug for the treatment of moderate to severe Restless Legs Syndrome.
The FDA announced that Requip, known generically as ropinirole hydrochloride, has been approved in tablet dosages of 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligrams, 3 milligrams, and 4 milligrams.
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Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc., all have been given the go-ahead to market ropinirole hydrochloride tablets.
Restless Legs Syndrome (RLS) is a neurological condition estimated to affect men and women equally within 5%-10% of the population, and while it can strike young children, most people who are severely affected are middle-aged or elderly.
The condition is characterized by an irresistible urge to move the legs. One of the most common complaints about RLS is that it causes difficulty falling or staying asleep, but the Restless Legs Syndrome Foundation says patients typically report uncomfortable sensations described as “creeping, itching, creepy-crawly, tugging, or gnawing.”
The FDA said labeling of the generic versions of ropinirole hydrochloride may differ from that of Requip because some uses of the drug are protected by patents. In addition to treating Restless Legs Syndrome, Requip is also FDA-approved to treat symptoms of Parkinson's disease.
The generic products are not approved for treatment of Parkinson's disease because this indication is protected by patent. Manufacturers of the generic drugs may seek approval for that use once the patent for the Parkinson's indication expires later this month.
The generic ropinirole hydrochloride tablets will have the same safety warnings as Requip, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving.
Although many of these patients reported sleepiness while on the drug, some patients perceived that they had no warning signs and believed that they were alert immediately prior to falling asleep. Some of these events have been reported as late as one year after the start of treatment.
(Article courtesy of

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