Treats inflammatory lesions of rosacea. NDA 213690, held by Journey. Minocycline Hydrochloride.
As of Nov 13, 2026, NDA 213690 (Zilxi), held by Journey, was first approved by FDA on May 28, 2020, with 1 approved supplement and 0 published complete response letters.
ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults. Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 2020 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZilxiEQ 1.5% BASE · aerosol, foam;topical | Minocycline Hydrochloride | RxReference drug |
| Feb 20, 2024 | Supplement 9Manufacturing | Approved | |
| May 28, 2020 | Original applicationNew formulation or manufacturer · 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
