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Laboratory researchers in a file photo.
The U.S. Food and Drug Administration approved on Friday the first generic
versions of Requip (ropinirole hydrochloride) tablets for the treatment of
moderate to severe Restless Legs Syndrome.(Xinhua/Reuters
File Photo) Photo
Gallery>>> |
WASHINGTON, May 8 (Xinhua) -- The U.S. Food and Drug
Administration approved on Friday the first generic versions of Requip
(ropinirole hydrochloride) tablets for the treatment of moderate to severe
Restless Legs Syndrome.
The following companies have received approval to
market ropinirole hydrochloride tablets: Roxane Laboratories Inc., Teva
Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc.
"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 Buehler, director of the FDA's Office of Generic
Drugs.
The labeling of the generic versions of ropinirole
hydrochloride may differ from that of Requip because some uses of the drug are
protected by patents. In addition to treating Restless Legs Syndrome, Requip is
also FDA-approved to treat symptoms of Parkinson's disease. The generic products
are 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, said FDA.