Neutropenia

• FDA approval · 2023-03-03
  FDA Approved: UDENYCA — Supplemental Application (Accord BioPharma, Inc.)

  The FDA approved a supplemental application for UDENYCA (pegfilgrastim-cbqv) by Accord BioPharma, Inc., to update the product labeling.

• FDA approval · 2022-11-28
  FDA Approved: UDENYCA — Supplemental Application (Accord BioPharma, Inc.)

  The FDA has approved a supplemental application for UDENYCA (pegfilgrastim-cbQV) submitted by Accord BioPharma, Inc.

• FDA approval · 2022-05-26
  FDA Approved: FYLNETRA — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves FYLNETRA (pegfilgrastim) from Amneal as an original biologics license application to help reduce the duration of neutropenia in…

• FDA approval · 2022-02-25
  FDA Approved: RELEUKO — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved RELEUKO (filgrastim) from Amneal Pharmaceuticals LLC under an Original Application (BLA 761082).

• FDA approval · 2021-06-07
  FDA Approved: UDENYCA — Supplemental Application (Accord BioPharma, Inc.)

  FDA approved a supplemental application for UDENYCA (pegfilgrastim-cbqv) from Accord BioPharma, Inc., under the biosimilars program.

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

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

• FDA approval · 2020-11-18
  FDA Approved: NEULASTA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for NEULASTA (pegfilgrastim) submitted by Amgen. The approval updates the product labeling based on …

• FDA approval · 2019-08-01
  FDA Approved: ZARXIO — Supplemental Application (Sandoz Inc.)

  The FDA approved a supplemental application for Zarxio (filgrastim-sndz) submitted by Sandoz Inc.

• FDA approval · 2019-05-29
  FDA Approved: FULPHILA — Supplemental Application (Biocon Biologics Inc.)

  FDA approved a supplemental application for Fulphila (pegfilgrastim-jmdb) from Biocon Biologics Inc., expanding its regulatory status.

• FDA approval · 2019-03-28
  FDA Approved: GRANIX — Supplemental Application (Cephalon, LLC)

  FDA approved a supplemental application for GRANIX (tbo-filgrastim) submitted by Cephalon, LLC.

• FDA approval · 2019-03-21
  FDA Approved: FULPHILA — Supplemental Application (Biocon Biologics Inc.)

  FDA supplemental approval for Fulphila (pegfilgrastim-jmdb) by Biocon Biologics Inc. to update/expand the approved labeling for this biosimi…

• FDA approval · 2018-11-02
  FDA Approved: UDENYCA — Original Application (Accord BioPharma, Inc.)

  FDA approved UDENYCA (pegfilgrastim-cbqv) as an original biologics license application for reducing the duration of neutropenia in patients …

• FDA approval · 2018-07-31
  FDA Approved: GRANIX — Supplemental Application (Cephalon, LLC)

  FDA approved a supplemental application for GRANIX (TBO-FILGRASTIM) submitted by Cephalon, LLC.

• FDA approval · 2018-07-20
  FDA Approved: NIVESTYM — Original Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved NIVESTYM (filgrastim-aafi) from Pfizer as a biosimilar to filgrastim for reducing duration of neutropenia and infection ris…

• FDA approval · 2018-06-18
  FDA Approved: NEUPOGEN — Supplemental Application (Amgen, Inc)

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

• 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 · 2017-06-21
  FDA Approved: GRANIX — Supplemental Application (Cephalon, LLC)

  FDA approved a supplemental application for GRANIX (TBO-FILGRASTIM) submitted by Cephalon, LLC. The approval updates GRANIX's regulatory sta…

• FDA approval · 2017-02-17
  FDA Approved: ZARXIO — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for ZARXIO (filgrastim-sndz) filed by Sandoz Inc.

• FDA approval · 2016-06-29
  FDA Approved: NEUPOGEN — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for NEUPOGEN (filgrastim) from Amgen, formalizing changes to its indication/label.

• 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 · 2012-08-29
  FDA Approved: GRANIX — Original Application (Cephalon, LLC)

  FDA approved Granix (tbo-filgrastim) through an original Biologics License Application filed by Cephalon, LLC.

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

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

• FDA approval · 2008-04-16
  FDA Approved: NEULASTA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for NEULASTA (pegfilgrastim) by Amgen, Inc., approving changes to the drug’s labeling and/or ind…

• FDA approval · 2007-07-23
  FDA Approved: NEULASTA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for NEULASTA (pegfilgrastim) from Amgen, authorizing changes to the existing labeling.