Ensitrelvir

FDA Drug Profile — XOCOVA

Ensitrelvir is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including XOCOVA. Available dosage form: tablet.

Drug Details

Generic Name
Ensitrelvir
Brand Names
XOCOVA
Application Number
NDA220442
Sponsor
Catalent Pharma Solutions, LLC
NDC Codes
2
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ENSITRELVIR

Indications and Usage

1 INDICATIONS AND USAGE XOCOVA is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease (M pro : also referred to as 3CL pro or nsp5 protease) inhibitor, is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID‑19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. ( 1 )