Chemotherapy-induced Nausea and Vomiting

• FDA approval · 2015-08-28
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2015-07-20
  FDA Approved: APREPITANT — Supplemental Application (Sandoz Inc)

  The FDA approved Sandoz Inc's supplemental application for aprepitant, enabling a generic version for prevention of chemotherapy-induced nau…

• FDA approval · 2015-07-13
  FDA Approved: ONDANSETRON — Original Application (Accord Healthcare, Inc.)

  FDA approves Accord Healthcare, Inc.'s original application for ondansetron, a generic antiemetic, for prevention of nausea and vomiting due…

• FDA approval · 2015-05-13
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved a supplemental application for AKYNZEO (netupitant and palonosetron) to update its labeling per Helsinn’s submission.

• FDA approval · 2015-04-29
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved a supplemental application for AKYNZEO (netupitant and palonosetron) to modify its labeling for prevention of chemotherapy-indu…

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• FDA approval · 2015-04-27
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  The FDA approved a supplemental application for AKYNZEO (netupitant and palonosetron) from Helsinn Therapeutics (U.S.), Inc., likely affecti…

• FDA approval · 2015-04-03
  FDA Approved: ONDANSETRON — Supplemental Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for ondansetron from Qilu Pharmaceutical Co., Ltd. (ANDA 203711), authorizing a supplemental submiss…

• FDA approval · 2015-03-30
  FDA Approved: CESAMET — Supplemental Application (Bausch Health US LLC)

  FDA approves a supplemental application for CESAMET (nabilone) from Bausch Health US LLC.

• FDA approval · 2015-03-18
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ondansetron hydrochloride by Sun Pharmaceutical Industries, expanding its approved use.

• FDA approval · 2015-03-02
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for ondansetron hydrochloride from Hikma Pharmaceuticals USA Inc., related to a generic product.

• FDA approval · 2015-02-16
  FDA Approved: AKYNZEO — Supplemental Application (Helsinn Therapeutics (U.S.), Inc.)

  FDA approved a supplemental application for AKYNZEO (netupitant and palonosetron) from Helsinn Therapeutics (U.S.), expanding its indication…

• FDA approval · 2015-01-17
  FDA Approved: ONDANSETRON — Supplemental Application (Eugia US LLC)

  The FDA approved a supplemental application for ondansetron hydrochloride from Eugia US LLC (ANDA 202599), granting regulatory approval for …

• FDA approval · 2015-01-15
  FDA Approved: ONDANSETRON — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for ondansetron filed by PAI Holdings dba PAI Pharma.

• FDA approval · 2015-01-15
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for ondansetron hydrochloride from Aurobindo Pharma Limited, enabling the generic product to adv…

• FDA approval · 2015-01-14
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for ondansetron hydrochloride from Chartwell RX, LLC., indicating approval of an additional formulat…

• FDA approval · 2015-01-12
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for EMEND (fosaprepitant dimeglumine) from Merck Sharp & Dohme LLC, updating its labeling for preven…

• FDA approval · 2015-01-12
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for EMEND (aprepitant) by Merck Sharp & Dohme LLC, updating the product's labeling and indications.

• FDA approval · 2015-01-09
  FDA Approved: ONDANSETRON — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for ondansetron supplied by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (ANDA 0792…

• FDA approval · 2014-12-31
  FDA Approved: ONDANSETRON — Supplemental Application (ACTAVIS PHARMA, INC.)

  FDA approved a supplemental application for ondansetron from Actavis Pharma, updating the approved product under the existing NDA.

• FDA approval · 2014-12-21
  FDA Approved: ONDANSETRON — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approves a supplemental application for ondansetron (generic) by Rising Pharma Holdings, Inc., adding another approved generic version.

• FDA approval · 2014-12-20
  FDA Approved: ONDANSETRON — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for ondansetron hydrochloride (ONDANSETRON) from Taro Pharmaceuticals U.S.A., Inc.

• FDA approval · 2014-12-20
  FDA Approved: ONDANSETRON — Supplemental Application (West-Ward Pharmaceuticals Corp)

  The FDA approved a supplemental application for ondansetron from West-Ward Pharmaceuticals Corp. (ANDA076780), indicating approval related t…

• FDA approval · 2014-12-10
  FDA Approved: ONDANSETRON — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for ondansetron by Hikma Pharmaceuticals USA Inc., enabling a generic version of the antiemetic to b…

• FDA approval · 2014-12-10
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for metoclopramide from Teva Pharmaceuticals USA, Inc., authorizing changes to the product's labelin…

• FDA approval · 2014-12-08
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for ondansetron hydrochloride by Fresenius Kabi USA, LLC under an ANDA, allowing continued manufactu…