CYFENDUS

STN: 125761 Proper Name: Anthrax Vaccine Adsorbed, Adjuvanted Tradename: CYFENDUS Manufacturer: Emergent BioDefense Operations Lansing LLC. Indication: CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted) is a vaccine indicated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The efficacy of CYFENDUS for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax. Product Information Package Insert and Patient Information - CYFENDUS Demographic Subgroup Information – Anthrax Vaccine Adsorbed, Adjuvanted (CYFENDUS) Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable. Supporting Documents November 5, 2025 Approval Letter - CYFENDUS July 20, 2023 Approval Letter - CYFENDUS July 20, 2023 Summary Basis for Regulatory Action - CYFENDUS Letters, Reviews, Related Documents-CYFENDUS