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FDA Approves Generic Ropinirole Hydrochloride for Treatment of Restless Legs Syndrome
ROCKVILLE, Md. -- May 9, 2008 -- The US Food and Drug Administration (FDA) has approved the generic ropinirole hydrochloride (Requip) tablets for the treatment of moderate to severe restless legs syndrome.
Ropinirole hydrochloride tablets have been approved in 0.25-, 0.5-, 1-, 2-, 3-, and 4-mg doses.
The labelling of the generic versions of ropinirole hydrochloride may differ from the brand-name drug because some uses of the medication are protected by patents. In addition to treating restless legs syndrome, the brand-name drug has also been approved by the FDA to treat symptoms of Parkinson's disease. However, the generic version of the medication is 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.
Ropinirole hydrochloride tablets will have the same safety warnings as the brand-name medication, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving.
"This generic drug approval is an example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary J. Buehler, Director, FDA, Office of Generic Drugs, Rockville, Maryland.
SOURCE: US Food and Drug Administration
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