Quofenix (delafloxacin)
- Region
- 🇪🇺 EU
- Active substance
- delafloxacin
- Company
- A. Menarini Industrie Farmaceutiche Riunite s.r.l.
- Status
- Authorised
- Therapeutic area
- Community-Acquired Infections
- CHMP opinion
- Thu 17 Oct 2019
- EU approval
- Mon 16 Dec 2019
- Application
- EMEA/H/C/004860
- ATC
- J01MA23
- Official record
- www.ema.europa.eu
Indication
Quofenix is indicated for the treatment of the following infections in adults: acute bacterial skin and skin structure infections (ABSSSI), community-acquired pneumonia (CAP), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Regulatory milestones
No milestones recorded in the last year.
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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.