News from the FDA/CDC

First generics for Gilenya approved by FDA


The Food and Drug Administration has approved the first generics of fingolimod (Gilenya) for the treatment of relapsing forms of multiple sclerosis.

The three generic fingolimod applications came from HEC Pharm, Biocon, and Sun Pharmaceutical Industries.

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Fingolimod is a widely used, orally administered treatment option for relapsing forms of multiple sclerosis in adults. The most common adverse events associated with fingolimod in clinical trials include headache, elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in the extremities.

The drug must be dispensed with a medication guide that contains important information on its usage and risk, the FDA noted. Serious risks associated with fingolimod include slowing of the heart rate, vision problems, posterior reversible encephalopathy syndrome, respiratory problems, liver injury, increased blood pressure, skin cancer, and risk of serious infection including a rare and often deadly brain infection called progressive multifocal leukoencephalopathy. Fingolimod can also cause harm to a developing fetus.

Find the full press release on the FDA website.

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