Chemotherapy-induced Nausea and Vomiting

• FDA approval · 2023-05-25
  FDA Approved: SUSTOL — Supplemental Application (Heron Therapeutics, Inc.)

  FDA approved a supplemental application for SUSTOL (granisetron) from Heron Therapeutics, Inc. The action concerns regulatory approval relat…

• FDA approval · 2023-05-24
  FDA Approved: ONDANSETRON — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Ondansetron, manufactured by Accord Healthcare, Inc., signaling an update to its regulatory stat…

• FDA approval · 2023-05-01
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Onesource Specialty Pharma Limited)

  The FDA approved a supplemental application for ondansetron hydrochloride from Onesource Specialty Pharma Limited, approving this generic an…

• FDA approval · 2023-05-01
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Onesource Specialty Pharma Limited)

  FDA approved a supplemental application for ondansetron hydrochloride submitted by Onesource Specialty Pharma Limited (ANDA 078257). This ac…

• FDA approval · 2023-04-26
  FDA Approved: ONDANSETRON — Supplemental Application (West-Ward Pharmaceuticals Corp)

  FDA approved a supplemental application for ondansetron submitted by West-Ward Pharmaceuticals Corp, indicating an approved change to an exi…

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• FDA approval · 2023-04-14
  FDA Approved: FOSAPREPITANT — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for fosaprepitant dimeglumine from NorthStar RxLLC.

• FDA approval · 2022-12-06
  FDA Approved: SANCUSO — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved Cumberland Pharmaceuticals' Supplemental Application for SANCUSO (granisetron), marking an updated approval for this antiemetic…

• FDA approval · 2022-11-09
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ondansetron hydrochloride from Sun Pharmaceutical Industries, Inc., under an ANDA. This docu…

• FDA approval · 2022-11-09
  FDA Approved: ONDANSETRON — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' supplemental application for ondansetron, an antiemetic. The approval indicates a change to the …

• FDA approval · 2022-09-21
  FDA Approved: DRONABINOL — Supplemental Application (Wellhouse Pharma, LLC)

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

• FDA approval · 2022-09-16
  FDA Approved: APONVIE — Original Application (Heron Therapeutics, Inc.)

  The FDA approved APONVIE, an intravenous formulation of aprepitant from Heron Therapeutics, under an original drug application for the preve…

• FDA approval · 2022-08-22
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Natco Pharma Limited)

  FDA approves a supplemental application for granisetron hydrochloride from Natco Pharma Limited.

• FDA approval · 2022-08-12
  FDA Approved: APREPITANT — Supplemental Application (Golden State Medical Supply, Inc.)

  FDA approved a supplemental application for APREPITANT from Golden State Medical Supply, Inc., under an ANDA.

• FDA approval · 2022-06-23
  FDA Approved: ONDANSETRON — Supplemental Application (NorthStar Rx LLC)

  The FDA approved a supplemental application for ondansetron hydrochloride (generic ondansetron) from NorthStar Rx LLC under ANDA078776. The …

• FDA approval · 2022-06-23
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for ondansetron hydrochloride from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2022-06-14
  FDA Approved: ONDANSETRON — Supplemental Application (AvPAK)

  FDA approved a supplemental application for ondansetron from AvPAK.

• FDA approval · 2022-06-10
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for ondansetron hydrochloride filed by Fresenius Kabi USA, LLC.

• FDA approval · 2022-06-10
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for ondansetron hydrochloride (ondansetron), a generic product manufactured by Fresenius Kabi USA, L…

• FDA approval · 2022-05-19
  FDA Approved: GRANISETRON — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for granisetron hydrochloride (granisetron) from Fresenius Kabi USA, LLC, expanding its regulatory a…

• FDA approval · 2022-05-02
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for EMEND (fosaprepitant dimeglumine) from Merck Sharp & Dohme LLC, updating the drug's regulato…

• FDA approval · 2022-04-28
  FDA Approved: CESAMET — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental application for Cesamet (nabilone) submitted by Bausch Health US LLC.

• FDA approval · 2022-03-15
  FDA Approved: ONDANSETRON — Supplemental Application (Hospira, Inc.)

  FDA approves Hospira, Inc.'s supplemental application for ondansetron, authorizing changes to the approved product.

• FDA approval · 2022-03-15
  FDA Approved: ONDANSETRON — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for ondansetron from Hospira, Inc., updating the product's approval under the ANDA.

• FDA approval · 2022-03-11
  FDA Approved: ONDANSETRON — Supplemental Application (JVET PHARMACEUTICALS LLC)

  The FDA approved a supplemental application for ondansetron from JVET PHARMACEUTICALS LLC, enabling this generic product's expanded approval…

• FDA approval · 2022-03-11
  FDA Approved: ONDANSETRON — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic ondansetron product from Heritage Pharmaceuticals (Avet) under the ANDA process.