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"Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an agency news release. "Having access to affordable treatments is important for patients with conditions that require ongoing care."
Many MS patients have periods of worsening function and onset of new symptoms (relapses) that are initially followed by periods of recovery (remissions). But, over time, recovery may be incomplete, resulting in increased disability. Gilenya is a widely used treatment in such cases.
In clinical trials for Gilenya, the most common side effects were headache, elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain and pain in the extremities, according to the FDA.
The approvals were granted to HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited.
MS is an inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and the rest of the body. It is one of the most common causes of neurological disability in young adults and occurs more often in women than men.
-- Robert Preidt
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