Treats chronic obstructive pulmonary disease (COPD). NDA 217389, held by Msd. Ensifentrine.
As of Nov 13, 2026, NDA 217389 (Ohtuvayre), held by Msd, was first approved by FDA on Jun 26, 2024, with 0 approved supplements and 0 published complete response letters.
OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 2024 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ohtuvayre3MG/2.5ML · suspension;inhalation | Ensifentrine | RxReference drug |
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
