Febrile Neutropenia

• FDA approval · 2026-04-07
  FDA Approved: CEFEPIME HYDROCHLORIDE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)

  FDA approved a supplemental application from B. Braun Medical Inc. for Cefepime hydrochloride and dextrose, adding this formulation under th…

• EMA approval · 2026-03-18
  EMA Authorised: Cegfila (previously Pegfilgrastim Mundipharma) (pegfilgrastim) — Mundipharma Corporation (Ireland) Limited

  The EMA authorised the pegfilgrastim product Cegfila (Mundipharma) for marketing in the European Union.

• EMA approval · 2026-02-24
  EMA Authorised: Vivlipeg (pegfilgrastim) — Biosimilar Collaborations Ireland Limited

  The EMA authorised Vivlipeg, a biosimilar pegfilgrastim. The product is indicated for neutropenia and related febrile neutropenia in cancer …

• EMA approval · 2026-02-19
  EMA Authorised: Fulphila (pegfilgrastim) — Biosimilar Collaborations Ireland Limited

  EMA authorised Fulphila, a pegfilgrastim biosimilar by Biosimilar Collaborations Ireland Limited. The approval covers its use to reduce the …

• EMA approval · 2025-12-08
  EMA Authorised: Neulasta (pegfilgrastim) — Amgen Europe B.V.

  EMA authorised Neulasta (pegfilgrastim) by Amgen Europe B.V. to reduce the risk of neutropenia, febrile neutropenia, and chemotherapy-induce…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-10-13
  FDA Approved: FULPHILA — Supplemental Application (Biocon Biologics Inc.)

  FDA approved a supplemental Biologics License Application for FULPHILA (pegfilgrastim-jmdb) by Biocon Biologics Inc.

• FDA approval · 2023-10-12
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Original Application (Eugia US LLC)

  FDA approved the original abbreviated new drug application for piperacillin and tazobactam, a combination antibiotic manufactured by Eugia U…

• FDA approval · 2022-03-18
  FDA Approved: CEFEPIME HYDROCHLORIDE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)

  FDA approved a supplemental application for Cefepime hydrochloride and dextrose from B. Braun Medical Inc.

• FDA approval · 2021-03-16
  FDA Approved: PIPERACILLIN AND TAZOBACTAM — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for Piperacillin and Tazobactam (piperacillin sodium and tazobactam sodium) submitted by Eugia U…

• 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 · 2019-04-16
  FDA Approved: UDENYCA — Supplemental Application (Accord BioPharma, Inc.)

  FDA approved a supplemental application for UDENYCA (pegfilgrastim-cbqv) from Accord BioPharma, authorizing a new or expanded use for the pr…

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

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

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

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

• FDA approval · 2008-03-20
  FDA Approved: CEFEPIME — Original Application (Sagent Pharmaceuticals)

  FDA records the original approval of cefepime hydrochloride (cefepime) for Sagent Pharmaceuticals under an ANDA. The approval concerns a bro…