Cancer Chemotherapy-induced Neutropenia

• FDA approval · 2025-08-21
  FDA Approved: ZARXIO — Supplemental Application (Sandoz Inc.)

  The FDA approved a supplemental application for Zarxio (filgrastim-sndz) submitted by Sandoz Inc. The action concerns updates under a supple…

• FDA label_change · 2025-08-18
  FDA Approved: NEULASTA — Supplemental Application (Amgen, Inc)

  FDA-approved a supplemental application for NEULASTA (pegfilgrastim) submitted by Amgen.

• FDA approval · 2024-08-09
  FDA Approved: ZARXIO — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for Zarxio (filgrastim-sndz) submitted by Sandoz Inc. Zarxio is a biosimilar to filgrastim used to m…

• FDA approval · 2024-01-19
  FDA Approved: ZARXIO — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for Zarxio (filgrastim-sndz) filed by Sandoz Inc., resulting in labeling changes under the supplemen…

• FDA approval · 2021-02-02
  FDA Approved: NEULASTA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for NEULASTA (pegfilgrastim) by Amgen, Inc.

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• FDA approval · 2018-06-04
  FDA Approved: FULPHILA — Original Application (Biocon Biologics Inc.)

  FDA approved Fulphila (pegfilgrastim-jmdb) from Biocon Biologics Inc. through an original application to help prevent neutropenia-related in…

• FDA approval · 2017-12-09
  FDA Approved: NEULASTA — Supplemental Application (Amgen, Inc)

  FDA approves a supplemental application for NEULASTA (pegfilgrastim) filed by Amgen, Inc.

• FDA approval · 2016-04-28
  FDA Approved: NEULASTA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for NEULASTA (pegfilgrastim) from Amgen, Inc. The approval updates the labeling related to its i…

• FDA approval · 2010-03-02
  FDA Approved: NEUPOGEN — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for NEUPOGEN (filgrastim) from Amgen, Inc.