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Ziextenzo FDA Approval History

Last updated by Judith Stewart, BPharm on June 12, 2020.

FDA Approved: Yes (First approved November 4, 2019)
Brand name: Ziextenzo
Generic name: pegfilgrastim-bmez
Dosage form: Injection
Company: Sandoz
Treatment for: Neutropenia Associated with Chemotherapy

Ziextenzo (pegfilgrastim-bmez) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) used to reduce the incidence of febrile neutropenia in patients treated with chemotherapy.

Development timeline for Ziextenzo

Nov  5, 2019Approval FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta
Apr  3, 2019Sandoz Resubmits Biosimilar Pegfilgrastim Application to US FDA
Dec  8, 2017Sandoz Announces New Phase I Data Showing Proposed Biosimilar Pegfilgrastim Matches Reference Medicine

Further information

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