Authority approves generic drug for ‘restless leg syndrome’

The US Food and Drug Administration (FDA), has approved a popular drug in the treatment of Parkinson’s Disease, as the first generic version of a drug for the treatment of moderate to severe Restless Leg Syndrome (RLS).

The FDA said that Requip, known generically as ropinirole hydrochloride, had been approved in tablet dosages of up to four milligrams, to help combat RLS, which is a neurological condition estimated to affect men and women equally within 5-10% of the population, with the most severely struck being the middle aged or elderly.

A common RLS complaint includes an irresistible urge to move the legs which leads to difficulty falling or staying asleep. Patients typically report uncomfortable sensations such as “creeping, itching, tugging, or gnawing”.

The generic tablets are not approved for treatment of Parkinson’s Disease because of existing patent protection.

But the generic ropinirole hydrochloride tablets for RLS treatment will have the same safety warnings as Requip, cautioning about reports of patients falling asleep, while engaged in activities of daily living, including driving cars.