abrocitinib

FDA Drug Profile — Cibinqo, CIBINQO

abrocitinib is listed in the FDA National Drug Code directory with 15 NDC codes, marketed under brand names including Cibinqo, CIBINQO. Available dosage form: tablet, film coated.

Drug Details

Generic Name
abrocitinib
Brand Names
Cibinqo, CIBINQO
Application Number
NDA213871
Sponsor
Pfizer Laboratories Div Pfizer Inc
NDC Codes
15
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. Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. 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.