← FDA DRUG APPROVALS

FDA NDA · NDA022527

GILENYA

fingolimod hcl

Sponsor: NOVARTIS

APPLICATION
NDA022527
TYPE
NDA
ORIGINAL APPROVAL
2010-09-21
LATEST ACTION
2025-08-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

GILENYA · ReferencePrescription
FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE · CAPSULE · ORAL
GILENYA · ReferencePrescription
FINGOLIMOD HYDROCHLORIDE EQ 0.25MG BASE · CAPSULE · ORAL

Approval history

2025-08-22Labeling · Supplement 44 · standard — Label ↗AP
2024-06-05Labeling · Supplement 42 · standard — Label ↗AP
2023-11-16Manufacturing (CMC) · Supplement 39 — Label ↗AP
2023-08-10Labeling · Supplement 38 · standard — Letter ↗AP
2019-12-26Labeling · Supplement 31 · standard — Letter ↗AP
2019-08-16Labeling · Supplement 29 · standard — Letter ↗AP
2019-08-16Labeling · Supplement 30 · standard — Letter ↗AP
2019-01-11Labeling · Supplement 26 · standard — Label ↗AP
2018-10-26Labeling · Supplement 27 · standard — Label ↗AP
2018-05-11Efficacy · Supplement 24 · priority — Label ↗AP
2017-12-15Labeling · Supplement 22 · standard — Letter ↗AP
2016-11-29REMS · Supplement 21 — Letter ↗AP
2016-02-19Labeling · Supplement 18 · standard — Letter ↗AP
2015-08-04Labeling · Supplement 19 · standard — Label ↗AP
2015-07-02Labeling · Supplement 16 · standard — Letter ↗AP
2015-05-14REMS · Supplement 15 — Letter ↗AP
2015-05-01Labeling · Supplement 13 · standard — Letter ↗AP
2014-08-22Manufacturing (CMC) · Supplement 14 · priorityAP
2014-04-30Labeling · Supplement 9 · standard — Label ↗AP
2013-05-28REMS · Supplement 10 — Letter ↗AP
2012-05-09Labeling · Supplement 8 · standard — Letter ↗AP
2012-03-18Labeling · Supplement 6 · unknown — Label ↗AP
2012-03-01REMS · Supplement 5 — Letter ↗AP
2011-07-20Efficacy · Supplement 2 · standard — Letter ↗AP
2011-07-01Labeling · Supplement 3 · unknown — Label ↗AP
2010-09-21Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →