Gilenya

Treats relapsing forms of multiple sclerosis (MS). NDA 22527, held by Novartis. Fingolimod Hydrochloride.

As of Nov 14, 2026, NDA 22527 (Gilenya), held by Novartis, was first approved by FDA on Sep 21, 2010, with 25 approved supplements and 0 published complete response letters.

First approved: Sep 21, 2010
Review: Priority
Supplements approved: 25
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

GILENYA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below


May 11, 2018	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric CDTL Review Pediatric Medical Review
Jul 20, 2011	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 21, 2010	Original applicationNew molecular entity · Priority review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms


GilenyaEQ 0.5MG BASE · capsule;oral	Fingolimod Hydrochloride	RxReference drug
GilenyaEQ 0.25MG BASE · capsule;oral	Fingolimod Hydrochloride	RxReference drug

All 26 submissions, including labeling and manufacturing supplements


Aug 22, 2025	Supplement 44Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 5, 2024	Supplement 42Labeling · Standard review	Approved	Letter Label
Nov 16, 2023	Supplement 39Manufacturing	Approved	Label
Aug 10, 2023	Supplement 38Labeling · Standard review	Approved	Label Letter
Dec 26, 2019	Supplement 31Labeling · Standard review	Approved	Label Letter
Aug 16, 2019	Supplement 30Labeling · Standard review	Approved	Letter Label
Aug 16, 2019	Supplement 29Labeling · Standard review	Approved	Letter Label
Jan 11, 2019	Supplement 26Labeling · Standard review	Approved	Letter Label
Oct 26, 2018	Supplement 27Labeling · Standard review	Approved	Label
May 11, 2018	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric CDTL Review Pediatric Medical Review
Dec 15, 2017	Supplement 22Labeling · Standard review	Approved	Label Letter
Nov 29, 2016	Supplement 21REMS	Approved	Letter
Feb 19, 2016	Supplement 18Labeling · Standard review	Approved	Letter Label
Aug 4, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
Jul 2, 2015	Supplement 16Labeling · Standard review	Approved	Letter Label
May 14, 2015	Supplement 15REMS	Approved	Letter
May 1, 2015	Supplement 13Labeling · Standard review	Approved	Letter Label
Aug 22, 2014	Supplement 14Manufacturing · Priority review	Approved	None posted
Apr 30, 2014	Supplement 9Labeling · Standard review	Approved	Label Letter
May 28, 2013	Supplement 10REMS	Approved	Letter
May 9, 2012	Supplement 8Labeling · Standard review	Approved	Letter Label
Mar 18, 2012	Supplement 6Labeling	Approved	Letter Label
Mar 1, 2012	Supplement 5REMS	Approved	Letter
Jul 20, 2011	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 1, 2011	Supplement 3Labeling	Approved	Label
Sep 21, 2010	Original applicationNew molecular entity · Priority review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22527
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters