Imitrex

Treats migraine with or without aura. NDA 20626, held by Glaxosmithkline. Sumatriptan.

As of Nov 14, 2026, NDA 20626 (Imitrex), held by Glaxosmithkline, was first approved by FDA on Aug 26, 1997, with 15 approved supplements and 0 published complete response letters.

First approved: Aug 26, 1997
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Sumatriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use:

Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan Nasal Spray, reconsider the diagnosis of migraine before Sumatriptan Nasal Spray is administered to treat any subsequent attacks.
Sumatriptan is not indicated for the prevention of migraine attacks.
Safety and effectiveness of Sumatriptan Nasal Spray 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 16 submissions below


Oct 13, 2004	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Aug 26, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Products

3 strengths and forms


Imitrex5MG/SPRAY · spray;nasal	Sumatriptan	RxReference drug
Imitrex10MG/SPRAY · spray;nasal	Sumatriptan	Discontinued
Imitrex20MG/SPRAY · spray;nasal	Sumatriptan	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Dec 9, 2025	Supplement 29Labeling · Standard review	Approved	Label Letter
Dec 14, 2017	Supplement 27Labeling · Standard review	Approved	Label Letter
Mar 25, 2016	Supplement 26Manufacturing · Standard review	Approved	None posted
Nov 25, 2013	Supplement 25Labeling · Standard review	Approved	Letter Label
Mar 1, 2012	Supplement 18Labeling · Standard review	Approved	Letter
Mar 1, 2012	Supplement 22Labeling	Approved	Label Letter
Jul 21, 2010	Supplement 13Labeling · Standard review	Approved	Label Letter
Jul 21, 2010	Supplement 15Labeling · Standard review	Approved	Label Letter
Jul 21, 2010	Supplement 16Labeling · Standard review	Approved	Label Letter
Oct 13, 2004	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jul 28, 2003	Supplement 7Labeling · Standard review	Approved	Review Letter
May 10, 2002	Supplement 6Labeling · Standard review	Approved	Letter
Dec 11, 2000	Supplement 3Labeling · Standard review	Approved	None posted
Jun 1, 2000	Supplement 1Labeling · Standard review	Approved	Review
Jun 1, 2000	Supplement 2Labeling · Standard review	Approved	Review
Aug 26, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20626
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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