Quick answers
- What is Sinuva?
- Sinuva is a brand name of Mometasone furoate, a prescription medicine. The FDA NDC Directory lists 1 Sinuva product in 1 strength and form.
- Who makes Sinuva?
- Intersect Ent Inc holds the FDA application for Sinuva (NDA209310, approved December 8, 2017).
- Is there a generic or store brand of Sinuva?
- Other products of Mometasone furoate are listed with the FDA, but none in exactly the same strength and form as a Sinuva product.
- Has Sinuva been recalled?
- FDA enforcement reports list 1 recall of Sinuva products; the newest started January 4, 2023. A recall usually concerns specific lots, not every product.
What Sinuva is
Each Sinuva product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Mometasone furoate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| mometasone furoate 1350 ug implant (intrasinal) | Sinuva | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Mometasone furoate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA209310 | Intersect Ent Inc | December 8, 2017 | 1 |
Companies that list Sinuva
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Sinuva products.
- Intersect ENT, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 4, 2023 · Class III · Terminated · D-0167-2023
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01. — Intersect ENT, Inc.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.