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Teva and Mylan get Requip approval
12 May 2008
Generic versions of a medication for Restless Legs Syndrome have been approved by US regulators.
The US Food and Drug Administration (FDA) announced on Friday that it has given Teva, Mylan, Roxane and Par Pharmaceuticals permission to market Requip tablets (also known as ropinirole hydrochloride) for the treatment of patients with moderate to severe symptoms of the syndrome.
Gary Buehler, director of the FDA's office of generic drugs, commented: "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."
Requip, which is also used to treat symptoms of Parkinson's disease, carries warnings about patients falling asleep after using the drug.
Some people said they were alert immediately before they fell asleep, with some patients drifting off while driving.
Israel-based Teva is one of the world's biggest generic drugmakers and Mylan is the largest manufacturer of generic transdermal patches.
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