Skip to Content

Gilenya Approval History

  • FDA approved: Yes (First approved September 21st, 2010)
  • Brand name: Gilenya
  • Generic name: fingolimod
  • Dosage form: Capsules
  • Previous name: FTY720
  • Company: Novartis
  • Treatment for: Multiple Sclerosis

Gilenya (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Development History and FDA Approval Process for Gilenya

May 11, 2018Approval FDA Expands Approval of Gilenya (fingolimod) to Treat Multiple Sclerosis in Pediatric Patients
Sep 22, 2010Approval Novartis Gains FDA Approval For Gilenya, A Novel First-Line Multiple Sclerosis Treatment Shown To Significantly Reduce Relapses And Delay Disability Progression
Jun 11, 2010FDA Advisory Committee Unanimously Recommends Approval Of Novartis Investigational Treatment FTY720 To Treat Relapsing Remitting MS
May 25, 2010Novartis Announces Extension of US Regulatory Priority Review Period for FTY720, an Investigational Once-daily Oral Multiple Sclerosis Therapy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.