Treats community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. NDA 211672, held by Hong Kong. Lefamulin Acetate.
As of Nov 13, 2026, NDA 211672 (Xenleta), held by Hong Kong, was first approved by FDA on Aug 19, 2019, with 2 approved supplements and 0 published complete response letters.
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. To reduce the development of drug resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Community-Acquired Bacterial Pneumonia (CABP)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| XenletaEQ 600MG BASE · tablet;oral | Lefamulin Acetate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 16, 2021 | Supplement 2Labeling · Standard review | Approved | |
| Oct 8, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Aug 19, 2019 | 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
