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# Almirall’s Seysara Label Update on Resistance
- URL: https://www.fdaweb.com/almiralls-seysara-label-update-on-resistance/
- Published: 2020-06-18T12:00:00.000Z
- Updated: 2026-09-14T16:18:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147045

FDA has approved a label update for Almirall’s Seysara (sarecycline) stating that *P. acnes* strains displayed a low propensity for developing resistance to sarecycline. This information is included in the Microbiology Section (12.4) of the prescribing information, the company says. Seysara, which was approved 10/2018, is described as a novel tetracycline-derived oral antibiotic developed specifically for treating acne. It is indicated for treating inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients nine years of age and older.

Almirall says the label update is based on data that demonstrated that *P. acnes* strains display low propensity for developing resistance to sarecycline, with spontaneous mutation frequencies being about 1 in 10 billion at four to eight times the minimum inhibitory concentration. This means that the main bacterium associated with acne has shown a very low potential of developing resistance to sarecycline, it says.