Zomig

Treats migraine with or without aura. NDA 21450, held by Amneal. Zolmitriptan.

As of Nov 15, 2026, NDA 21450 (Zomig), held by Amneal, was first approved by FDA on Sep 30, 2003, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 30, 2003
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ZOLMITRIPTAN NASAL SPRAY is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use Only use ZOLMITRIPTAN NASAL SPRAY if a clear diagnosis of migraine has been established. If a patient has no response to ZOLMITRIPTAN NASAL SPRAY treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOLMITRIPTAN NASAL SPRAY is administered to treat any subsequent attacks. ZOLMITRIPTAN NASAL SPRAY is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOLMITRIPTAN 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 6 submissions below


Jun 12, 2015	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 16, 2013	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 14, 2008	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter
Sep 30, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label Letter Pediatric Medical Review

Products

2 strengths and forms


Zomig2.5MG/SPRAY · spray;nasal	Zolmitriptan	RxReference drug
Zomig5MG/SPRAY · spray;nasal	Zolmitriptan	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Dec 21, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 12, 2015	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 16, 2013	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 14, 2008	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter
Jul 2, 2004	Supplement 1Labeling · Standard review	Approved	Letter
Sep 30, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label Letter Pediatric Medical Review

Identifiers

Application: NDA 21450
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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