Chemotherapy-induced Nausea and Vomiting

• FDA label_change · 2023-02-15
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved a supplemental application for AKYNZEO (fosnetupitant and palonosetron) to update the labeling for prevention of chemotherapy-i…

• FDA label_change · 2022-03-14
  FDA Approved: CINVANTI — Supplemental Application (Heron Therapeutics, Inc.)

  FDA approved a supplemental application for CINVANTI (aprepitant) submitted by Heron Therapeutics, Inc. The action involves changes to the p…

• FDA label_change · 2022-02-28
  FDA Approved: ONDANSETRON — Supplemental Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for ondansetron from Qilu Pharmaceutical Co., Ltd., likely resulting in labeling changes for this ge…

• FDA label_change · 2020-05-27
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved a supplemental application for AKYNZEO (fosnetupitant and palonosetron) submitted by Helsinn Therapeutics (U.S.), Inc., typical…

• FDA label_change · 2018-03-07
  FDA Approved: ONDANSETRON — Supplemental Application (AvPAK)

  FDA listing shows a supplemental application for ondansetron by AvPAK, likely related to changes to labeling or approved indications for thi…

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• FDA label_change · 2017-05-25
  FDA Approved: DRONABINOL — Supplemental Application (Wellhouse Pharma, LLC)

  FDA approved a supplemental application for dronabinol from Wellhouse Pharma, LLC (NDA205525).

• FDA label_change · 2017-03-27
  FDA Approved: ONDANSETRON — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for ondansetron from PAI Pharma, resulting in changes to the product labeling.

• FDA label_change · 2016-12-28
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved a supplemental labeling application for AKYNZEO (netupitant and palonosetron) submitted by Helsinn Therapeutics (U.S.), Inc., u…

• FDA label_change · 2016-04-22
  FDA Approved: VARUBI — Supplemental Application (TerSera Therapeutics LLC)

  FDA approved a supplemental application for VARUBI (rolapitant) submitted by TerSera Therapeutics LLC to update the product label.

• FDA label_change · 2015-10-09
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for ondansetron hydrochloride from Fresenius Kabi USA, LLC (ANDA202253), typically involving labelin…

• FDA label_change · 2015-09-28
  FDA Approved: SANCUSO — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved Cumberland Pharmaceuticals' supplemental application for SANCUSO (granisetron), expanding its label for the prevention of chemo…

• FDA label_change · 2015-07-20
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approves a supplemental application for AKYNZEO (netupitant and palonosetron) to update its labeling for the prevention of chemotherapy-…

• FDA label_change · 2013-11-19
  FDA Approved: SANCUSO — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  The FDA approved a Cumberland Pharmaceuticals supplemental application for SANCUSO (granisetron). The approval typically involves changes to…

• FDA label_change · 2007-08-30
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for palonosetron hydrochloride by Cipla USA Inc., resulting in updated labeling for the product.