Treats acute otitis externa (AOE) with or without an otowick, caused by susceptible…. NDA 206307, held by Fonseca Biosciences. Finafloxacin.
As of Nov 13, 2026, NDA 206307 (Xtoro), held by Fonseca Biosciences, was first approved by FDA on Dec 17, 2014, with 3 approved supplements and 0 published complete response letters.
XTORO is indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 2014 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xtoro0.3% · suspension/drops;otic | Finafloxacin | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2026 | Supplement 4Labeling · Standard review | Approved | |
| Mar 18, 2026 | Supplement 6Labeling · Standard review | Approved | |
| Dec 29, 2015 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 17, 2014 | 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
