Actavis issued the following announcement on Aug. 6.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved GRANIX® (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients 1 month and older. GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
The new vial presentation of the product will be available for use in 300mcg/1mL and 480mcg/1.6mL single-dose vials. The prefilled syringe presentations will continue to be available as well.
“The new pediatric indication and vial presentation of GRANIX expand the range of treatment options that can be of benefit to both patients and healthcare providers,” said Brendan O’Grady, EVP and Head of North America Commercial at Teva.
GRANIX was approved by the FDA in August 2012. GRANIX vials are expected to be available in the U.S. shortly.
Original source can be found here.