Mayzent

Treats relapsing forms of multiple sclerosis (MS). NDA 209884, held by Novartis. Siponimod.

As of Nov 13, 2026, NDA 209884 (Mayzent), held by Novartis, was first approved by FDA on Mar 26, 2019, with 13 approved supplements and 0 published complete response letters.

First approved: Mar 26, 2019
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MAYZENT 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 adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Mar 1, 2022	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 26, 2019	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

3 strengths and forms


MayzentEQ 0.25MG BASE · tablet;oral	Siponimod	RxReference drug
MayzentEQ 2MG BASE · tablet;oral	Siponimod	RxReference drug
MayzentEQ 1MG BASE · tablet;oral	Siponimod	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Jun 30, 2026	Supplement 21Labeling · Standard review	Approved	Label Medication Guide Letter
Aug 21, 2025	Supplement 20Labeling · Standard review	Approved	Label Letter
Jun 5, 2024	Supplement 19Labeling · Standard review	Approved	Letter Label
Aug 10, 2023	Supplement 16Labeling · Standard review	Approved	Label Letter
Aug 10, 2023	Supplement 18Labeling · Standard review	Approved	Label
Jan 31, 2023	Supplement 15Labeling · Standard review	Approved	Letter Label
Jun 21, 2022	Supplement 11Labeling · Standard review	Approved	Label Letter
Jun 10, 2022	Supplement 10Labeling · Standard review	Approved	Label Letter
Mar 1, 2022	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 10, 2021	Supplement 5Labeling · Standard review	Approved	Letter
Aug 24, 2021	Supplement 6	Approved	Label Letter
Jan 23, 2021	Supplement 3Labeling · Standard review	Approved	Letter Label
Jul 31, 2020	Supplement 2Labeling · Standard review	Approved	Label Letter
Mar 26, 2019	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 209884
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