FDA approves new indication, vial presentation for Teva's Granix
Teva has received the green light from the Food and Drug Administration for a new indication and vial presentation of its Neupogen biosimilar, Granix (tbo-filgrastim), the company announced Tuesday. It is now indicated in pediatric patients one month old and older.
The product is indicated to reduce the duration of severe neutropenia in adult and pediatric patients one month old and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Teva said the product will now be available in 300 mcg/1 ml and 480 mcg/1.6 ml single-dose vials, with its prefilled syringe presentation still available.
“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, Teva’s executive vice president and head of North America commercial.
The product is indicated to reduce the duration of severe neutropenia in adult and pediatric patients one month old and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Teva said the product will now be available in 300 mcg/1 ml and 480 mcg/1.6 ml single-dose vials, with its prefilled syringe presentation still available.
“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, Teva’s executive vice president and head of North America commercial.