FDA approves first generics of Gilenya

December 11, 2019
The U.S. Food and Drug Administration approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis in adult patients.

Gilenya is a widely used orally administered treatment option. 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.

According to MS Focus senior medical advisor Dr. Ben Thrower, the same first dose observations for Gilyena, which require being watched in a medical setting for six hours after taking the first pill for heat arrhythmias, will be needed for the generics.

The FDA granted approvals of generic fingolimod applications to HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited.

Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to more affordable medicines.

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