tbo-filgrastim

FDA Drug Profile — GRANIX

Drug Details

Generic Name
tbo-filgrastim
Brand Names
GRANIX
Application Number
BLA125294
Sponsor
Cephalon, LLC
NDC Codes
4
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
FILGRASTIM

Indications and Usage

1 INDICATIONS AND USAGE GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated in adult and pediatric patients 1 month and older for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1 )