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.

Related UPI Stories
Latest Headlines
Trending News
Seattle sea otter learns how to use an inhaler
Catholic conservatives wary of Pope's climate change message
Apple signals delivery of electric car by 2019, report says
Self-impregnated snake in Missouri has another 'virgin birth'
Ancient Roman village found in Germany