Maxalt-Mlt

Treats migraine with or without aura. NDA 20865, held by Organon. Rizatriptan Benzoate.

As of Nov 14, 2026, NDA 20865 (Maxalt-Mlt), held by Organon, was first approved by FDA on Jun 29, 1998, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 29, 1998
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MAXALT and MAXALT-MLT are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks. MAXALT is not indicated for use in the management of hemiplegic or basilar migraine. MAXALT is not indicated for the prevention of migraine attacks. Safety and effectiveness of MAXALT have not been established for cluster headache.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Dec 16, 2011	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 11, 2000	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review
Jun 21, 2000	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review
Nov 16, 1999	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter
Jun 29, 1998	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Maxalt-MltEQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, orally disintegrating;oral	Rizatriptan Benzoate	DiscontinuedReference drug
Maxalt-MltEQ 10MG BASE · tablet, orally disintegrating;oral	Rizatriptan Benzoate	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Oct 1, 2019	Supplement 24Labeling · Standard review	Approved	Label Letter
May 29, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 16, 2011	Supplement 12Labeling · Standard review	Approved	Letter Label
Dec 16, 2011	Supplement 16Labeling · Standard review	Approved	Letter Label
Dec 16, 2011	Supplement 18Labeling · Standard review	Approved	Letter Label
Dec 16, 2011	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 16, 2011	Supplement 21Labeling · Standard review	Approved	Letter Label
Aug 12, 2010	Supplement 14Labeling · Standard review	Approved	Label Letter
Apr 22, 2002	Supplement 9Labeling · Standard review	Approved	Review Letter
Dec 6, 2001	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 23, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 11, 2000	Supplement 5Labeling · Standard review	Approved	Review
Dec 11, 2000	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Review
Dec 11, 2000	Supplement 7Labeling · Standard review	Approved	Review
Jun 21, 2000	Supplement 2	Approved	Review
Jun 21, 2000	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review
Mar 28, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 16, 1999	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter
Jun 29, 1998	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20865
Drugs@FDA: Overview at FDA
Company: Organon

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