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Zarxio FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved March 6, 2015)
Brand name: Zarxio
Generic name: filgrastim-sndz
Dosage form: Injection
Company: Sandoz Inc.
Treatment for: Neutropenia Associated with Chemotherapy

Zarxio (filgrastim-sndz) is a leukocyte growth factor biosimilar to the reference product Neupogen, indicated for the treatment of neutropenia associated with chemotherapy.

Development timeline for Zarxio

DateArticle
Mar  6, 2015Approval FDA Approves First Biosimilar Product Zarxio (filgrastim-sndz)
Jan  7, 2015Sandoz Biosimilar Filgrastim Recommended for Approval

Further information

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