FDA Approves First Generic Versions Of Requip For Restless Legs Syndrome

The U.S Food and Drug Administration (FDA) has approved first generic versions of Requip (ropinirole hydrochloride) for the treatment of moderate to severe Restless Leg Syndrome (RLS).

Gary J. Buehler, Director of the FDA’s office of the Generic Drugs, said that the approval of this generic drug is an example of the FDA’s efforts for increasing access to safe and effective generic drugs as soon as the law permits.

The drug has been approved in the following dosages: 0.25 milligram, 0.5 milligram, 1milligram, 2 milligram, 3 milligram, and 4 milligram.

In addition to treating Restless Legs Syndrome, Requip is also approved to treat symptoms of Parkinson’s disease.

The safety warnings for generic ropinirole hydrochloride tablets will be same as Requip, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving.

Many patients reported sleepiness while on the drug, but some patients perceived that they had no warning signs and were alert immediately prior to falling asleep. These warning signs have been reported as late as one year after the start of treatment.

Source: News-Medical