Chemotherapy-induced Nausea and Vomiting

• FDA approval · 2010-03-23
  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 · 2009-12-23
  FDA Approved: GRANISETRON HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves an original application for granisetron hydrochloride (generic) by Hikma Pharmaceuticals USA Inc. as a generic antiemetic to pr…

• FDA approval · 2009-12-01
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved Ipca Laboratories Limited's supplemental application for Metoclopramide, granting approval of a generic version of the drug. Th…

• FDA approval · 2009-11-06
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's metoclopramide product, updating its regulatory status as a marketed generic drug.

• FDA approval · 2009-09-25
  FDA Approved: ONDANSETRON — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved an original ANDA for ondansetron from Heritage Pharmaceuticals (Avet) as a generic antiemetic to prevent nausea and vomiting du…

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• FDA approval · 2009-09-04
  FDA Approved: REGLAN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for REGLAN (metoclopramide hydrochloride), enabling changes under a supplemen…

• FDA approval · 2009-07-21
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2009-06-30
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for metoclopramide.

• FDA approval · 2009-02-02
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for EMEND (aprepitant) from Merck Sharp & Dohme LLC to update the labeling for prevention of che…

• FDA approval · 2009-02-02
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2008-12-05
  FDA Approved: CESAMET — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for CESAMET (nabilone) from Bausch Health US LLC. The action updates the product labeling per th…

• FDA approval · 2008-11-18
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for EMEND (aprepitant) by Merck Sharp & Dohme LLC. The approval expands the labeling to include …

• FDA approval · 2008-10-28
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for metoclopramide from ANI Pharmaceuticals, Inc., for an already approved generic product. This…

• FDA approval · 2008-10-23
  FDA Approved: ONDANSETRON — Supplemental Application (AvKARE)

  FDA approved a supplemental application for Ondansetron from AvKARE under ANDA078152, authorizing the generic product's marketing.

• FDA approval · 2008-09-12
  FDA Approved: SANCUSO — Original Application (Cumberland Pharmaceuticals Inc.)

  The FDA approved SANCUSO (granisetron) under an original NDA by Cumberland Pharmaceuticals Inc. for the prevention of chemotherapy-induced n…

• FDA approval · 2008-08-18
  FDA Approved: ONDANSETRON — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for ondansetron from Glenmark Pharmaceuticals Inc., USA, for a generic product; this action may invo…

• FDA approval · 2008-08-18
  FDA Approved: ONDANSETRON — Supplemental Application (AvKARE)

  FDA approved a supplemental application for AvKARE's ondansetron (ANDA 078152), resulting in labeling updates for the product. The action co…

• FDA approval · 2008-06-30
  FDA Approved: GRANISETRON — Original Application (Fresenius Kabi USA, LLC)

  FDA approved an original application for granisetron hydrochloride (granisetron) by Fresenius Kabi USA, LLC, a generic antiemetic.

• FDA approval · 2008-06-27
  FDA Approved: DRONABINOL — Original Application (Rhodes Pharmaceuticals L.P.)

  FDA approves Rhodes Pharmaceuticals' original application for dronabinol (a generic), with indications for chemotherapy-induced nausea and v…

• FDA approval · 2008-04-23
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Original Application (Onesource Specialty Pharma Limited)

  FDA approved the original application for ondansetron hydrochloride (generic) from Onesource Specialty Pharma Limited.

• FDA approval · 2008-04-23
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Original Application (Onesource Specialty Pharma Limited)

  FDA approved ondansetron hydrochloride under an Original Application (ANDA078257) for use as an antiemetic. The generic product is developed…

• FDA approval · 2008-02-29
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Supplemental Application (Cipla USA Inc.)

  FDA granted supplemental approval for palonosetron hydrochloride from Cipla USA Inc. under NDA 021372.

• FDA approval · 2008-02-13
  FDA Approved: GRANISETRON HYDROCHLORIDE — Original Application (Bionpharma Inc.)

  FDA approved the original application for granisetron hydrochloride by Bionpharma Inc., enabling the generic product. Granisetron hydrochlor…

• FDA approval · 2008-01-25
  FDA Approved: EMEND — Original Application (Merck Sharp & Dohme LLC)

  FDA approved EMEND (fosaprepitant dimeglumine) from Merck Sharp & Dohme LLC as an original New Drug Application (NDA022023).

• FDA approval · 2008-01-04
  FDA Approved: ONDANSETRON — Supplemental Application (Chartwell RX, LLC)

  FDA granted a supplemental approval for ondansetron (Chartwell RX, LLC) under an ANDA.