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# FDA Reg Review for Xepi Determined
- URL: https://www.fdaweb.com/fda-reg-review-for-xepi-determined/
- Published: 2020-07-13T12:00:00.000Z
- Updated: 2026-09-14T16:20:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147174

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Toyama Chemical Co.’s , Xepi (ozenoxacin), indicated for topical treatment of impetigo due to *Staphylococcus aureus* or *Streptococcus pyogenes* in adult and pediatric patients two months of age and older. The regulatory review period was determined to be 2,819 days, which includes 2,282 days that occurred during the testing phase and 537 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-07-13/pdf/2020-15013.pdf?ref=fdaweb.com).