Treats migraine, with or without aura, and the acute treatment of cluster headache. NDA 20080, held by Glaxosmithkline. Sumatriptan Succinate.
As of Nov 13, 2026, NDA 20080 (Imitrex, Imitrex Statdose (Autoinjector)), held by Glaxosmithkline, was first approved by FDA on Dec 28, 1992, with 30 approved supplements and 0 published complete response letters.
IMITREX injection is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache. Limitations of Use
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 1, 2006 | Supplement 36Efficacy (new indication or use) | Approved | |
| May 22, 1996 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Dec 28, 1992 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| ImitrexEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;subcutaneous | Sumatriptan Succinate | DiscontinuedReference drug |
| Imitrex Statdose (Autoinjector)EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) · solution;subcutaneous | Sumatriptan Succinate | RxReference drug |
| Imitrex Statdose (Autoinjector)EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) · solution;subcutaneous | Sumatriptan Succinate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 9, 2025 | Supplement 55Labeling · Standard review | Approved | |
| Dec 20, 2021 | Supplement 54Labeling · Standard review | Approved | |
| Mar 23, 2021 | Supplement 53Labeling · Standard review | Approved | |
| Jul 17, 2018 | Supplement 52Labeling · Standard review | Approved | |
| Dec 14, 2017 | Supplement 50Labeling · Standard review | Approved | |
| Nov 19, 2015 | Supplement 49Labeling · Standard review | Approved | |
| Jun 11, 2015 | Supplement 48Labeling · Standard review | Approved | |
| Oct 2, 2012 | Supplement 45Labeling | Approved | |
| Oct 2, 2012 | Supplement 41Labeling · Standard review | Approved | |
| Oct 2, 2012 | Supplement 40Labeling · Standard review | Approved | |
| Oct 2, 2012 | Supplement 39Labeling · Standard review | Approved | |
| Jul 21, 2010 | Supplement 38Labeling · Standard review | Approved | |
| Feb 1, 2006 | Supplement 36Efficacy (new indication or use) | Approved | |
| Jul 28, 2003 | Supplement 30Labeling · Standard review | Approved | |
| Jan 3, 2003 | Supplement 29Labeling · Standard review | Approved | |
| Feb 2, 2001 | Supplement 27Labeling · Standard review | Approved | None posted |
| Feb 2, 2001 | Supplement 26Labeling · Standard review | Approved | None posted |
| Feb 2, 2001 | Supplement 25Labeling · Standard review | Approved | None posted |
| Feb 2, 2001 | Supplement 24Labeling · Standard review | Approved | None posted |
| Feb 2, 2001 | Supplement 21Labeling · Standard review | Approved | None posted |
| Dec 16, 1997 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Nov 26, 1997 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Dec 23, 1996 | Supplement 5Manufacturing · Priority review | Approved | |
| May 22, 1996 | Supplement 4Efficacy (new indication or use) | Approved | None posted |
| Mar 28, 1996 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Nov 29, 1995 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Oct 5, 1995 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Jun 7, 1995 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Aug 17, 1994 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 30, 1993 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Dec 28, 1992 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
