everolimus

FDA Drug Profile — everolimus, EVEROLIMUS, Everolimus, Afinitor, Zortress

Drug Details

Generic Name
everolimus
Brand Names
everolimus, EVEROLIMUS, Everolimus, Afinitor, Zortress, Afinitor Disperz
Application Number
ANDA219533
Sponsor
Novartis Pharma Stein AG
NDC Codes
44
Dosage Forms
TABLET, TABLET, FOR SUSPENSION, POWDER
Routes
ORAL
Active Ingredients
EVEROLIMUS

Indications and Usage

1 INDICATIONS AND USAGE Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. ( 1.5 ) 1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) Everolimus tablets for oral suspension are indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected.