Treats chronic rhinosinusitis with nasal polyps. NDA 209310, held by Intersect Ent Inc. Mometasone Furoate.
As of Nov 14, 2026, NDA 209310 (Sinuva), held by Intersect Ent Inc, was first approved by FDA on Dec 8, 2017, with 3 approved supplements and 0 published complete response letters.
SINUVA Sinus Implant is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥18 years of age who have had ethmoid sinus surgery.
| Apr 28, 2020 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 8, 2017 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sinuva1.35MG · implant;implantation | Mometasone Furoate | RxReference drug |
| Jan 20, 2023 | Supplement 6Labeling · Standard review | Approved | |
| Apr 28, 2020 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jan 12, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Dec 8, 2017 | 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
