First Generic Ropinirole, Approved by The FDA

Filed in archive FDA Approvals , Neurological Disorders , Treatment on May 9, 2008

Requip (ropinirole hydrochloride) tablets - product of GlaxoSmithKline (GSK) - are for the treatment of moderate to severe Restless Legs Syndrome (RLS).


© Brymo



From the NINDS-NIH:

Restless legs syndrome (RLS) is a neurological disorder characterized by unpleasant sensations in the legs and an uncontrollable urge to move when at rest in an effort to relieve these feelings. RLS sensations are often described by people as burning, creeping, tugging, or like insects crawling inside the legs. Often called paresthesias (abnormal sensations) or dysesthesias (unpleasant abnormal sensations), the sensations range in severity from uncomfortable to irritating to painful.

Now the FDA has approved the generic versions of Requip - Ropinirole Hydrochloride. The said generics approved are from the following generic drug makers:

• Roxane Laboratories Inc.


• Teva Pharmaceuticals USA


• Par Pharmaceuticals Inc.


• Mylan Pharmaceuticals Inc.

Read more from the FDA News.