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See the DrugPatentWatch profile for Delafloxacin
Delafloxacin (generic) – U.S. launch | Milestone | Date | |-----------|------| | FDA approval (first‑in‑class fluoroquinolone for acute bacterial skin & skin‑structure infections and complicated urinary tract infections) | August 7, 2019 | | First commercial sale in the U.S. (brand name Baxdela) | August 7, 2019 |
The drug was approved by the Food and Drug Administration (FDA) on August 7 2019 and went straight to market in the United States under the brand name Baxdela. It is the first new fluoroquinolone approved in the U.S. in more than 15 years. ---
| Milestone | Date | |-----------|------| | EMA approval (acute bacterial skin & skin‑structure infections) | September 11, 2015 |
In Europe, delafloxacin received its first marketing authorisation in 2015 under the brand name Baxdela (for ABSSSI). It was later approved in the EU for complicated urinary tract infections in 2018. ---
- U.S. launch date: August 7, 2019 - First EU launch date: September 11, 2015 Feel free to ask if you’d like more details on its indications, dosing, or regulatory background.
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