FDA approves generic Requip tablets

May 12, 2008 at 10:14 AM

WASHINGTON, May 12 (UPI) -- The U.S. Food and Drug Administration has approved the first generic versions of a drug designed for the treatment of restless legs syndrome.

The FDA said it approved Requip (ropinirole hydrochloride) in dosages of 0.25 milligrams, 0.5 milligrams, 1 milligram, 2 milligrams, 3 milligrams and 4 milligrams.

The marketing approval went to Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc. and Mylan Pharmaceuticals Inc.

While Requip is also FDA-approved to treat symptoms of Parkinson's disease, the generic products aren't approved for that purpose because that is protected by patent. However, the FDA said the patent expires this month, at which time manufacturers of the generic drugs may seek approval for that use.

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