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FDA Approves Generic Drug for Restless Legs Syndrome

Requip also approved for treatment of Parkinson's disease

May 12, 2008

Restless Legs • FDA Approves Generic Drug for Restless Legs Syndrome • Restless Legs Syndrome Doubles Risk of Stroke, Heart Disease • Restless Legs Syndrome Linked With Heart Ailments • Researchers Find "Restless Leg" Gene • FDA Approves Drug for Restless Legs Syndrome

The Food and Drug Administration has approved the first generic versions of a drug for the treatment of moderate to severe Restless Legs Syndrome.

Requip (ropinirole hydrochloride) tablets have been approved in dosages of 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligrams, 3 milligrams, and 4 milligram4.

Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc., have been given the go ahead to market ropinirole hydrochloride tablets.

The 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 disease 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.

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