Chemotherapy-induced Nausea and Vomiting

• FDA approval · 2017-03-24
  FDA Approved: ONDANSETRON — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for ondansetron from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2017-03-24
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ondansetron hydrochloride from Sun Pharmaceutical Industries, Inc., under the ANDA.

• FDA approval · 2017-02-14
  FDA Approved: ONDANSETRON — Supplemental Application (ACTAVIS PHARMA, INC.)

  The FDA approved a supplemental application for ondansetron tablets from Actavis Pharma, Inc. under the ANDA, signifying an approved change …

• FDA approval · 2017-02-07
  FDA Approved: ONDANSETRON — Supplemental Application (AvPAK)

  FDA approves a supplemental application for ondansetron submitted by AvPAK.

• FDA approval · 2016-12-02
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

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

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• FDA approval · 2016-11-08
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for granisetron hydrochloride (generic) from Mylan Institutional LLC.

• FDA approval · 2016-11-08
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approves a supplemental application for granisetron hydrochloride from Mylan Institutional LLC, expanding access for this generic antiem…

• FDA approval · 2016-09-28
  FDA Approved: APREPITANT — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for aprepitant filed by Sandoz Inc., updating the regulatory status for the drug.

• FDA approval · 2016-08-09
  FDA Approved: SUSTOL — Original Application (Heron Therapeutics, Inc.)

  FDA approved SUSTOL (granisetron) from Heron Therapeutics via an original NDA for prevention of chemotherapy-induced nausea and vomiting in …

• FDA approval · 2016-07-01
  FDA Approved: DRONABINOL — Original Application (Wellhouse Pharma, LLC)

  FDA approved dronabinol under an original NDA submitted by Wellhouse Pharma, LLC.

• FDA approval · 2016-06-09
  FDA Approved: FOSAPREPITANT — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fosaprepitant from Fresenius Kabi USA, LLC under an Original Application (ANDA) to prevent chemotherapy-induced nausea and vomi…

• FDA approval · 2016-04-21
  FDA Approved: PALONOSETRON — Original Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's palonosetron as an original application (ANDA201533) for preventing postoperative and chemotherapy-induced n…

• FDA approval · 2016-04-12
  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., expanding the …

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

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

• FDA approval · 2016-03-03
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for ondansetron hydrochloride submitted by Chartwell RX, LLC as an ANDA amendment.

• FDA approval · 2016-03-01
  FDA Approved: POSFREA — Original Application (Avyxa Pharma, LLC)

  The FDA approved POSFREA (palonosetron) from Avyxa Pharma, marking the original approval of this antiemetic for prevention of chemotherapy-i…

• FDA approval · 2016-02-28
  FDA Approved: ONDANSETRON — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's supplemental application for ondansetron (ondansetron).

• FDA approval · 2016-02-01
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2015-12-17
  FDA Approved: EMEND — Original Application (Merck Sharp & Dohme LLC)

  FDA approved EMEND (aprepitant) from Merck as the original application for prevention of acute and delayed chemotherapy-induced nausea and v…

• FDA approval · 2015-10-26
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Onesource Specialty Pharma Limited)

  FDA approved a supplemental application for ondansetron hydrochloride from Onesource Specialty Pharma Limited. This action updates the regul…

• FDA approval · 2015-10-26
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Onesource Specialty Pharma Limited)

  FDA approved a supplemental ANDA for ondansetron hydrochloride from Onesource Specialty Pharma Limited under the ANDA.

• FDA approval · 2015-10-22
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for ondansetron hydrochloride (ondansetron) submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2015-10-13
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Original Application (Sandoz Inc)

  FDA approved Palonosetron hydrochloride from Sandoz Inc via an Original Application (ANDA) for use in preventing chemotherapy- and postopera…

• FDA approval · 2015-09-28
  FDA Approved: ONDANSETRON — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for ondansetron from Chartwell RX, LLC, authorizing a generic version of the antiemetic.

• FDA approval · 2015-09-01
  FDA Approved: VARUBI — Original Application (TerSera Therapeutics LLC)

  Varubi (rolapitant) received FDA approval as an antiemetic to prevent chemotherapy-induced nausea and vomiting in adults undergoing initial …