Chemotherapy-induced Nausea and Vomiting

• FDA approval · 2022-03-01
  FDA Approved: ONDANSETRON — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for a generic ondansetron hydrochloride product from Eugia US LLC under ANDA 202600. This approv…

• FDA approval · 2021-11-12
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Original Application (Baxter Healthcare Corporation)

  FDA approved palonosetron hydrochloride from Baxter Healthcare Corporation under an original application. The drug is indicated to prevent c…

• FDA approval · 2021-10-01
  FDA Approved: ONDANSETRON — Supplemental Application (AvPAK)

  The FDA approved a supplemental application for ondansetron submitted by AvPAK.

• FDA approval · 2021-10-01
  FDA Approved: ONDANSETRON — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare, Inc.'s supplemental application for ondansetron, indicating an approved change to the product's labeling.

• FDA approval · 2021-09-01
  FDA Approved: ONDANSETRON — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for ondansetron by Hospira, Inc., a generic antiemetic. Ondansetron is used to prevent postoperative…

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• FDA approval · 2021-09-01
  FDA Approved: ONDANSETRON — Supplemental Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for ondansetron submitted by Qilu Pharmaceutical Co., Ltd. (ANDA 203711).

• FDA approval · 2021-08-19
  FDA Approved: ONDANSETRON — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental ANDA from Eugia US LLC for ondansetron hydrochloride (ondansetron), establishing a generic product.

• FDA approval · 2021-08-19
  FDA Approved: ONDANSETRON — Supplemental Application (Eugia US LLC)

  FDA approves a supplemental application for ondansetron hydrochloride (Ondansetron) submitted by Eugia US LLC.

• FDA approval · 2021-08-16
  FDA Approved: ONDANSETRON — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for ondansetron by Hikma Pharmaceuticals USA Inc., confirming the continued availability/approval of…

• FDA approval · 2021-07-29
  FDA Approved: FOSAPREPITANT — Original Application (NorthStar RxLLC)

  FDA approved the original application for fosaprepitant dimeglumine (fosaprepitant) from NorthStar RxLLC to prevent chemotherapy-induced nau…

• FDA approval · 2021-06-29
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Original Application (Avenacy, Inc.)

  FDA approved palonosetron hydrochloride under an Original Abbreviated New Drug Application for Avenacy, Inc.

• FDA approval · 2021-06-02
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approves a supplemental application for AKYNZEO (netupitant and palonosetron) from Helsinn Therapeutics (U.S.), Inc.

• FDA approval · 2021-06-02
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved a supplemental indication for AKYNZEO (fosnetupitant and palonosetron) to prevent chemotherapy-induced nausea and vomiting in p…

• FDA approval · 2021-03-03
  FDA Approved: FOSAPREPITANT — Original Application (Avenacy, LLC)

  FDA approved the original application for Fosaprepitant (fosaprepitant dimeglumine) by Avenacy, LLC, a generic antiemetic indicated to preve…

• FDA approval · 2021-01-12
  FDA Approved: FOSAPREPITANT DIMEGLUMINE — Original Application (Eugia US LLC)

  FDA approved the original application for fosaprepitant dimeglumine from Eugia US LLC, a generic NK1 receptor antagonist for preventing chem…

• FDA approval · 2021-01-06
  FDA Approved: FOSAPREPITANT — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Fosaprepitant from Fresenius Kabi USA, LLC under an ANDA.

• FDA approval · 2020-12-23
  FDA Approved: APREPITANT — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for aprepitant submitted by Sandoz Inc.

• FDA approval · 2020-12-09
  FDA Approved: FOSAPREPITANT — Original Application (Dr. Reddy's Laboratories Inc.,)

  FDA approved the original application for fosaprepitant from Dr. Reddy's Laboratories, granting a generic formulation of the antiemetic used…

• FDA approval · 2020-10-27
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved a supplemental application for AKYNZEO (fosnetupitant and palonosetron) from Helsinn Therapeutics (U.S.), Inc.

• FDA approval · 2020-10-21
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for palonosetron hydrochloride by Sandoz Inc under ANDA 202521. The approval confirms the generic pr…

• FDA approval · 2020-10-21
  FDA Approved: APREPITANT — Original Application (Golden State Medical Supply, Inc.)

  FDA approved the original application for aprepitant, granting a generic version of this antiemetic to expand access.

• FDA approval · 2020-09-08
  FDA Approved: FOSAPREPITANT DIMEGLUMINE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved fosaprepitant dimeglumine from Hikma as a generic injectable antiemetic to prevent chemotherapy- and postoperative-induced naus…

• FDA approval · 2020-08-17
  FDA Approved: FOSAPREPITANT — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for fosaprepitant (generic) submitted by Mylan Institutional LLC.

• FDA approval · 2020-04-30
  FDA Approved: SANCUSO — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  The FDA approved Cumberland Pharmaceuticals' supplemental application for SANCUSO (granisetron). This action approves an additional regulato…

• FDA approval · 2020-04-01
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for palonosetron hydrochloride from Cipla USA Inc.