Chemotherapy-induced Nausea and Vomiting

• FDA approval · 2018-04-23
  FDA Approved: ONDANSETRON — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for ondansetron hydrochloride from Taro Pharmaceuticals U.S.A., Inc., for an already approved pr…

• FDA approval · 2018-04-19
  FDA Approved: AKYNZEO — Original Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved the original application for AKYNZEO, a fixed-dose combination of fosnetupitant and palonosetron, to prevent chemotherapy-induc…

• FDA approval · 2018-04-13
  FDA Approved: VARUBI — Supplemental Application (TerSera Therapeutics LLC)

  FDA approved a supplemental application for VARUBI (rolapitant) submitted by TerSera Therapeutics LLC.

• FDA approval · 2018-04-12
  FDA Approved: DRONABINOL — Supplemental Application (Wellhouse Pharma, LLC)

  The FDA approved a supplemental application for dronabinol submitted by Wellhouse Pharma, LLC.

• FDA approval · 2018-04-03
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for EMEND (fosaprepitant dimeglumine) by Merck Sharp & Dohme LLC.

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• FDA approval · 2018-03-26
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for EMEND (fosaprepitant dimeglumine) from Merck Sharp & Dohme LLC.

• FDA approval · 2018-03-23
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Original Application (Teva Parenteral Medicines, Inc.)

  FDA approved Teva Parenteral Medicines' palonosetron hydrochloride injection as an original application (ANDA 090713), establishing bioequiv…

• FDA approval · 2018-03-14
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for ondansetron hydrochloride from Chartwell RX, LLC, under the ANDA process.

• FDA approval · 2018-03-07
  FDA Approved: ONDANSETRON — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  The FDA approved a supplemental application for ondansetron under an ANDA held by PAI Holdings dba PAI Pharma, indicating a supplemental reg…

• FDA approval · 2018-03-07
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for ondansetron hydrochloride from Aurobindo Pharma Limited, granting approval of this generic p…

• FDA approval · 2018-03-07
  FDA Approved: ONDANSETRON — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for ondansetron hydrochloride (ONDANSETRON) from NorthStar Rx LLC, resulting in updated labeling for…

• FDA approval · 2018-03-07
  FDA Approved: ONDANSETRON — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for ondansetron from Rising Pharma Holdings, Inc., marking an update to the generic's labeling or po…

• FDA approval · 2018-02-26
  FDA Approved: ONDANSETRON — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for ondansetron filed by Chartwell RX, LLC.

• FDA approval · 2018-02-26
  FDA Approved: ONDANSETRON — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for ondansetron submitted by Chartwell RX, LLC, approving a generic ondansetron product.

• FDA approval · 2018-02-13
  FDA Approved: ONDANSETRON — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for ondansetron submitted by Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2018-02-13
  FDA Approved: ONDANSETRON — Supplemental Application (AvKARE)

  FDA approved a supplemental application for AvKARE's ondansetron, a generic antiemetic, indicating an addition or modification to the approv…

• FDA approval · 2017-11-09
  FDA Approved: CINVANTI — Original Application (Heron Therapeutics, Inc.)

  The FDA approved CINVANTI (aprepitant) under an original NDA from Heron Therapeutics for preventing chemotherapy-induced nausea and vomiting…

• FDA approval · 2017-10-12
  FDA Approved: APREPITANT — Original Application (BluePoint Laboratories)

  FDA approved the original application for a generic aprepitant (APREPITANT) from BluePoint Laboratories, confirming a generic version of the…

• FDA approval · 2017-09-13
  FDA Approved: SANCUSO — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved Cumberland Pharmaceuticals' supplemental application for SANCUSO (granisetron). The granisetron product is used to prevent chem…

• FDA approval · 2017-08-28
  FDA Approved: DRONABINOL — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for dronabinol from Ascend Laboratories, LLC.

• FDA approval · 2017-08-09
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for EMEND (fosaprepitant dimeglumine) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2017-05-31
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for EMEND (aprepitant) from Merck Sharp & Dohme LLC.

• FDA approval · 2017-05-31
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for EMEND (aprepitant) filed by Merck Sharp & Dohme LLC.

• FDA approval · 2017-03-30
  FDA Approved: ONDANSETRON — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark Pharmaceuticals’ supplemental application for ondansetron (generic antiemetic) under ANDA077535.

• FDA approval · 2017-03-27
  FDA Approved: ONDANSETRON — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for ondansetron submitted by Rising Pharma Holdings, Inc.