Treats dry eye disease. NDA 213978, held by Harrow Eye. Varenicline Tartrate.
As of Nov 13, 2026, NDA 213978 (Tyrvaya), held by Harrow Eye, was first approved by FDA on Oct 15, 2021, with 1 approved supplement and 0 published complete response letters.
TYRVAYA (varenicline solution) nasal spray is indicated for the treatment of the signs and symptoms of dry eye disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2021 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TyrvayaEQ 0.03MG BASE/SPRAY · spray;nasal | Varenicline Tartrate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 2024 | Supplement 5Labeling · Standard review | Approved | |
| Oct 15, 2021 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
