Treats migraine with or without aura. NDA 212728, held by Pfizer. Rimegepant Sulfate.
As of Nov 13, 2026, NDA 212728 (Nurtec Odt), held by Pfizer, was first approved by FDA on Feb 27, 2020, with 10 approved supplements and 0 published complete response letters.
NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: acute treatment of migraine with or without aura in adults preventive treatment of episodic migraine in adults 1.1 Acute Treatment of Migraine NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults. 1.2 Preventive Treatment of Episodic Migraine NURTEC ODT is indicated for the preventive treatment of episodic migraine in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 11, 2022 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| May 27, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Feb 27, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nurtec OdtEQ 75MG BASE · tablet, orally disintegrating;oral | Rimegepant Sulfate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2026 | Supplement 32Labeling · Standard review | Approved | |
| Mar 16, 2026 | Supplement 29Labeling · Standard review | Approved | |
| Aug 1, 2025 | Supplement 28Labeling · Standard review | Approved | |
| Mar 21, 2025 | Supplement 26Labeling · Standard review | Approved | |
| Dec 12, 2024 | Supplement 25Labeling · Standard review | Approved | |
| Apr 11, 2022 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Mar 31, 2022 | Supplement 14Manufacturing | Approved | |
| Dec 8, 2021 | Supplement 12Labeling · Standard review | Approved | |
| May 27, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Aug 18, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Feb 27, 2020 | Original applicationNew molecular entity · Priority review | Approved |
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
