Maxalt

Treats migraine with or without aura. NDA 20864, held by Organon LLC. Rizatriptan Benzoate.

As of Nov 13, 2026, NDA 20864 (Maxalt), held by Organon LLC, was first approved by FDA on Jun 29, 1998, with 17 approved supplements and 0 published complete response letters.

First approved: Jun 29, 1998
Review: Standard
Supplements approved: 17
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 18 submissions below


Dec 16, 2011	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 11, 2000	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review
Jun 21, 2000	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
Nov 16, 1999	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter
Jun 29, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

2 strengths and forms


MaxaltEQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Rizatriptan Benzoate	DiscontinuedReference drug
MaxaltEQ 10MG BASE · tablet;oral	Rizatriptan Benzoate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Oct 1, 2019	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 15, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
May 29, 2014	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 16, 2011	Supplement 11Labeling · Standard review	Approved	Letter Label
Dec 16, 2011	Supplement 16Labeling · Standard review	Approved	Letter Label
Dec 16, 2011	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 16, 2011	Supplement 18Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 16, 2011	Supplement 19Labeling · Standard review	Approved	Letter Label
Aug 12, 2010	Supplement 13Labeling · Standard review	Approved	Label Letter
Apr 22, 2002	Supplement 8Labeling · Standard review	Approved	Review Letter
Dec 6, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 25, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 11, 2000	Supplement 4Labeling · Standard review	Approved	Review
Dec 11, 2000	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review
Dec 11, 2000	Supplement 7Labeling · Standard review	Approved	Review
Jun 21, 2000	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review
Nov 16, 1999	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter
Jun 29, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 20864
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