abrocitinib

FDA Drug Profile — Cibinqo, CIBINQO

Drug Details

Generic Name
abrocitinib
Brand Names
Cibinqo, CIBINQO
Application Number
NDA213871
Sponsor
Pfizer Laboratories Div Pfizer Inc
NDC Codes
9
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
ABROCITINIB

Indications and Usage

1 INDICATIONS AND USAGE CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. CIBINQO is a Janus kinase (JAK) inhibitor indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. ( 1 ) Limitation of Use : CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.