Treats complicated intra‑abdominal infections. NDA 211109, held by Tetraphase Pharms. Eravacycline Dihydrochloride.
As of Nov 13, 2026, NDA 211109 (Xerava), held by Tetraphase Pharms, was first approved by FDA on Aug 27, 2018, with 4 approved supplements and 0 published complete response letters.
XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.1 Complicated Intra-abdominal Infections
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| XeravaEQ 50MG BASE/VIAL · powder;intravenous | Eravacycline Dihydrochloride | RxReference drug |
| XeravaEQ 100MG BASE/VIAL · powder;intravenous | Eravacycline Dihydrochloride | RxReference drug |
| Mar 31, 2025 | Supplement 14Labeling · Standard review | Approved | |
| Dec 13, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Jun 3, 2020 | Supplement 4Manufacturing | Approved | |
| Jun 18, 2019 | Supplement 1Manufacturing | Approved | None posted |
| Aug 27, 2018 | Original applicationNew molecular entity · Priority 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
