Imitrex

Treats migraine with or without aura. NDA 20132, held by Glaxosmithkline. Sumatriptan Succinate.

As of Nov 14, 2026, NDA 20132 (Imitrex), held by Glaxosmithkline, was first approved by FDA on Jun 1, 1995, with 22 approved supplements and 0 published complete response letters.

First approved: Jun 1, 1995
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

IMITREX tablets are 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 IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks.
IMITREX is not indicated for the prevention of migraine attacks.
Safety and effectiveness of IMITREX tablets have not been established for cluster headache. IMITREX is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Feb 13, 1998	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 1, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


ImitrexEQ 100MG BASE · tablet;oral	Sumatriptan Succinate	RxReference drug
ImitrexEQ 25MG BASE · tablet;oral	Sumatriptan Succinate	RxReference drug
ImitrexEQ 50MG BASE · tablet;oral	Sumatriptan Succinate	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Dec 9, 2025	Supplement 31Labeling · Standard review	Approved	Label Letter
Mar 23, 2021	Supplement 30Labeling · Standard review	Approved	Label Letter
Dec 14, 2017	Supplement 29Labeling · Standard review	Approved	Label Letter
Nov 25, 2013	Supplement 28Labeling · Standard review	Approved	Letter Label
Mar 1, 2012	Supplement 26Labeling	Approved	Label Letter
Mar 1, 2012	Supplement 24Labeling · Standard review	Approved	Letter
Aug 11, 2010	Supplement 22Labeling · Standard review	Approved	Label Letter
Aug 11, 2010	Supplement 21Labeling · Standard review	Approved	Label Letter
Aug 11, 2010	Supplement 20Labeling · Standard review	Approved	Label Letter
Aug 11, 2010	Supplement 13Labeling · Standard review	Approved	Label Letter
Jun 17, 2004	Supplement 18Labeling · Standard review	Approved	Letter
Jul 28, 2003	Supplement 14Labeling · Standard review	Approved	Review Letter
Jun 30, 2003	Supplement 15Manufacturing · Standard review	Approved	Review
Jun 25, 2001	Supplement 12Labeling · Standard review	Approved	None posted
Jun 25, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 9, 2001	Supplement 10Labeling · Standard review	Approved	None posted
Feb 9, 2001	Supplement 8Labeling · Standard review	Approved	None posted
Feb 9, 2001	Supplement 7Labeling · Standard review	Approved	None posted
Feb 24, 1998	Supplement 6Labeling · Standard review	Approved	None posted
Feb 13, 1998	Supplement 3Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 16, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 28, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 1, 1995	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20132
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