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First Generics Of Gilenya Gets Approval

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The U.S. Food and Drug Administration has approved three generic versions of Novartis' Gilenya capsule for treating relapsing forms of multiple sclerosis.

"Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines."

The three generic applications approved by the FDA have been licensed to HEC Pharm Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited.

Multiple Sclerosis is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men.

The most common side effects reported in the clinical trials for Gilenya include headache, elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain and pain in the extremities.

Developed by Novartis, Gilenya was the first oral disease-modifying therapy to be approved by the FDA and the European Commission for the treatment of adults and children with relapsing-remitting multiple sclerosis, age 10 and older.

The drug works by preventing immune cells from reaching the brain and spinal cord, reducing inflammation, disease progression, and the risk of MS relapses.

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