Treats bronchoconstriction. NDA 22007, held by Viatris Specialty. Formoterol Fumarate.
As of Nov 13, 2026, NDA 22007 (Perforomist), held by Viatris Specialty, was first approved by FDA on May 11, 2007, with 9 approved supplements and 0 published complete response letters.
Formoterol fumarate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 11, 2007 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Perforomist0.02MG/2ML · solution;inhalation | Formoterol Fumarate | RxReference drug |
| May 29, 2019 | Supplement 15Labeling · Standard review | Approved | |
| Oct 17, 2018 | Supplement 14Labeling · Standard review | Approved | |
| Nov 30, 2017 | Supplement 12Labeling · Standard review | Approved | |
| Mar 19, 2014 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 25, 2012 | Supplement 7REMS | Approved | |
| Sep 25, 2012 | Supplement 8REMS | Approved | |
| Jan 11, 2012 | Supplement 6Labeling | Approved | |
| Feb 1, 2011 | Supplement 5REMS | Approved | |
| Jun 2, 2010 | Supplement 4Labeling | Approved | |
| May 11, 2007 | Original applicationNew dosage form · Standard 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
