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Gilenya Approval History

FDA Approved: Yes (First approved September 21, 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

DateArticle
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

Further information

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