Three generic applications for Novarma generic Gilenya have been approved by the FDA

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Novartis, the Swiss pharmaceutical giant, announced that three generic applications of its generic drug, Gilenya, had been approved by the FDA for HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited. It is reported that the drug will be used in adult patients with multiple sclerosis (MS).Gilenya is understood to have received FDA approval for the first time in 2010 to treat adults with relapsed sclerosis. On May 11, 2019, the FDA approved Novartis' Gilenya for the treatment of multiple sclerosis (MS) in children and adolescents 10 years of age and older, the first fda approval for a drug for the treatment of pediatric MS.Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said, "The approval of safe and effective generic drugs to give patients more treatment options remains a priority for the FDA. Affordable treatments are critical for patients in need of ongoing care, so the FDA has a long history of delivering low-cost, high-quality generics to patients. Msis a central nervous demyelination disorder that disrupts communication between the brain and other parts of the body. It is one of the most common causes of neurological disorders in young people, and the incidence rate is higher in women than in men. For most people with MS, it is initially a deterioration of function and the emergence of new symptoms, known as relapses or seizures, followed by a recovery period. However, over time, recovery may be incomplete and may even lead to a gradual decline in functionality and increased barriers. On top of this, Novart's Gilenya is a widely used oral treatment.The most common side effects reported in Gilenya's clinical trials include headache, elevated liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and limb pain.Gilenya must issue a drug guide that contains important information about its use and risks. Serious risks include slowing heart rhythms, especially after the first drug is given. In addition, Gilenya may increase the risk of serious infection, so patients need to be monitored for infection during treatment and two months after suspension.In addition, Gilenya may cause vision problems; it may increase the risk of swelling and narrowing of blood vessels in the brain (post-reversible encephalopathy syndrome); and the drug may also cause harm to developing fetuses. Other serious risks include respiratory problems, liver damage, elevated blood pressure and skin cancer. (Arterial mesh)