Treats inflammatory lesions of non-nodular moderate to severe acne vulgaris. NDA 212379, held by Journey. Minocycline Hydrochloride.
As of Nov 14, 2026, NDA 212379 (Amzeeq), held by Journey, was first approved by FDA on Oct 18, 2019, with 2 approved supplements and 0 published complete response letters.
AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. 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, AMZEEQ should be used only as indicated. AMZEEQ is a tetracycline-class drug indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 18, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AmzeeqEQ 4% BASE · aerosol, foam;topical | Minocycline Hydrochloride | RxReference drug |
| Jan 13, 2022 | Supplement 7Manufacturing | Approved | |
| Jan 29, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Oct 18, 2019 | 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
