FDA Approves First Generics of Novartis MS Drug Gilenya

The U.S. Food and Drug Administration approved three applications for first generics of Novartis AG’s Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis in adult patients, according to a statement from the regulator.

• FDA granted approvals of generic fingolimod applications to HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited
• NOTE: July 8, Novartis Could Stave Off Gilenya Generics Past 2021, Later

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