Treats inflammatory lesions of non-nodular moderate to severe acne vulgaris. NDA 209521, held by Almirall. Sarecycline Hydrochloride.
As of Nov 14, 2026, NDA 209521 (Seysara), held by Almirall, was first approved by FDA on Oct 1, 2018, with 4 approved supplements and 0 published complete response letters.
SEYSARA (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA 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, SEYSARA should be used only as indicated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 1, 2018 | Original applicationNew molecular entity · Standard review | Approved |
| SeysaraEQ 60MG BASE · tablet;oral | Sarecycline Hydrochloride | RxReference drug |
| SeysaraEQ 100MG BASE · tablet;oral | Sarecycline Hydrochloride | RxReference drug |
| SeysaraEQ 150MG BASE · tablet;oral | Sarecycline Hydrochloride | RxReference drug |
| Mar 30, 2023 | Supplement 15Labeling · Standard review | Approved | |
| Mar 30, 2023 | Supplement 16Labeling · Standard review | Approved | |
| Jun 1, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Apr 9, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Oct 1, 2018 | Original applicationNew molecular entity · 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
