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# Regulatory Review Period for Cipla’s Zemdri
- URL: https://www.fdaweb.com/regulatory-review-period-for-ciplas-zemdri/
- Published: 2023-05-16T12:00:00.000Z
- Updated: 2026-09-14T18:32:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154456

*Federal Register* notice: FDA has determined for patent term extension purposes the regulatory review period for Cipla USA’s Zemdri (plazomicin), indicated for treating patients 18 years of age or older with complicated urinary tract infections. The review period was 3,447 days, of which 3,203 days occurred during the testing phase and 244 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-05-15/pdf/2023-10316.pdf?ref=fdaweb.com).