Xenleta (lefamulin)
- Region
- 🇪🇺 EU
- Active substance
- lefamulin
- Company
- Venipharm
- Status
- Authorised
- Therapeutic area
- Pneumonia, Bacterial; Community-Acquired Infections
- EU approval
- Mon 27 Jul 2020
- Application
- EMEA/H/C/005048
- ATC
- J01XX
- Official record
- www.ema.europa.eu
Indication
Xenleta is indicated for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Regulatory milestones
No milestones recorded in the last year.
Follow Xenleta
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.