CYFENDUS
STN: 125761
Proper Name: Anthrax Vaccine Adsorbed, Adjuvanted
Tradename: CYFENDUS
Manufacturer: Emergent Product Development Gaithersburg Inc.
Indication:
- 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
Product Information
- Package Insert - CYFENDUS
- 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
- July 20, 2023 Approval Letter - CYFENDUS
- July 20, 2023 Summary Basis for Regulatory Action - CYFENDUS
- Approval History, Letters, Reviews, and Related Documents - CYFENDUS