The Food and Drug Administration said Friday it granted four companies approval to market the first generic versions of GlaxoSmithKline's drug for restless leg syndrome Requip.
Patients with the twitching condition experience compelling urges to move their legs, which can interfere with sleep.
The companies approved to market low-cost versions of Requip are Roxane Laboratories Inc., Par Pharmaceuticals Inc., Teva Pharmaceuticals USA and Mylan Pharmaceuticals Inc.
FDA approved six dosing levels of the drug, ranging from 0.25 milligrams to 4 milligrams
Requip generated U.S. sales of $518 million last year for doses ranging between 0.25 milligrams and 5 milligrams, according to IMS Health, an industry statistics firm.
Requip stimulates dopamine receptors in the brain that control body movement. The drug is also approved to treat Parkinson's disease, though FDA said the new generic drugs are not currently indicated for that use. When the patent on treatment of Parkinson's disease with Requip expires later this month, companies will be able to apply for FDA approval of that use.
The generic versions will carry the same warnings as Requip, including reports of patients falling asleep while driving and performing other tasks.
Shares of GlaxoSmithKline PLC fell 52 cents to $43.87 in midday trading Friday.
Terms & Conditions
RSS Headlines
Fool UK