Ropinirole hydrochloride is used to treat moderate to severe restless legs syndrome (RLS). In addition to treating restless legs syndrome with ropinirole hydrochloride, FDA also approved this method for treating Parkinson's disease. Because the use of treating Parkinson's disease is protected by patent, this generic drug ropinirole hydrochloride can only be approved for treating restless legs syndrome. Once the patent for treating Parkinson's disease in the original factory expires, generic drug manufacturers may seek permission to treat Parkinson's disease. Therefore, the approved instructions are different from the original drug instructions in terms of treatment scope.
Restless leg syndrome (RLS) is a common neuropathy, with an incidence of 5% ~ 10% in the population. And there is an obvious upward trend with the increase of age. The main features of restless legs syndrome are indescribable discomfort, ants walking, leg pain and swelling of patients, which are aggravated at night or at rest and can be temporarily relieved after exercise. In severe cases, it can invade the upper limbs and cause sleep disorders at night, fatigue and lethargy during the day, and even more serious cases may have mental symptoms such as anxiety and depression. FDA officials believe that the approval of generic drugs in ropinirole hydrochloride once again shows that the FDA is trying to provide consumers with and increase the availability of safe and effective generic drugs when permitted by law.
The safety warning information of Requip, the original research drug of ropinirole hydrochloride Tablet, is also applicable to generic drugs, reminding patients that the drug has sedative effect, may have drowsiness symptoms, and may fall asleep in daily activities such as driving. After taking the medicine, the time for patients to appear the above symptoms is different. Some patients will appear immediately after taking the medicine, and some patients will appear after one year of treatment.
At present, Roxane Laboratory Company, Teva Pharmaceutical Company, Par Pharmaceutical Company and Mylan Pharmaceutical Company of the United States have obtained the marketing license of generic drugs in ropinirole hydrochloride.