Chemotherapy-induced Nausea and Vomiting

• FDA approval · 2012-03-08
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for metoclopramide from Ipca Laboratories Limited.

• FDA approval · 2012-02-17
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for ondansetron hydrochloride from Hikma Pharmaceuticals USA Inc., resulting in the approval of a ge…

• FDA approval · 2012-02-13
  FDA Approved: ONDANSETRON — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's supplemental application for ondansetron hydrochloride (generic ondansetron) under ANDA 0761…

• FDA approval · 2011-12-07
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Natco Pharma Limited)

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

• FDA approval · 2011-10-17
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ondansetron hydrochloride API from Aurobindo Pharma Limited.

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• FDA approval · 2011-09-30
  FDA Approved: ONDANSETRON — Supplemental Application (AvKARE)

  FDA approved a supplemental application for AvKARE's ondansetron, confirming continued approval to produce and supply the drug.

• FDA approval · 2011-09-23
  FDA Approved: SANCUSO — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental application for SANCUSO (granisetron) from Cumberland Pharmaceuticals Inc., updating the product's labeling.

• FDA approval · 2011-04-01
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for Granisetron Hydrochloride (generic) filed by Mylan Institutional LLC. This action confirms appro…

• FDA approval · 2011-02-25
  FDA Approved: ONDANSETRON — Supplemental Application (Fresenius Kabi USA, LLC)

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

• FDA approval · 2011-01-31
  FDA Approved: ONDANSETRON — Supplemental Application (West-Ward Pharmaceuticals Corp)

  FDA approved a supplemental application for ondansetron submitted by West-Ward Pharmaceuticals Corp.

• FDA approval · 2011-01-31
  FDA Approved: ONDANSETRON — Original Application (AvPAK)

  FDA approved Ondansetron under AvPAK's original generic application (ANDA 091483) to prevent nausea and vomiting associated with chemotherap…

• FDA approval · 2011-01-27
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Original Application (Chartwell RX, LLC.)

  FDA approved an original ANDA for ondansetron hydrochloride (generic) by Chartwell RX, LLC, expanding available generic options for the anti…

• FDA approval · 2011-01-20
  FDA Approved: ONDANSETRON — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for ondansetron hydrochloride from NorthStar Rx LLC, confirming continued approval of this generic a…

• FDA approval · 2011-01-04
  FDA Approved: ONDANSETRON HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ondansetron hydrochloride from Aurobindo Pharma Limited, adding a new generic product under an A…

• FDA approval · 2010-12-08
  FDA Approved: ONDANSETRON — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for ondansetron from Rising Pharma Holdings, Inc. under the ANDA process, indicating an approved…

• FDA approval · 2010-11-30
  FDA Approved: ONDANSETRON — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for ondansetron hydrochloride from Dr. Reddy's Laboratories Limited, allowing continued approval…

• FDA approval · 2010-11-30
  FDA Approved: ONDANSETRON — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for ondansetron submitted by Hikma Pharmaceuticals USA, indicating a regulatory update to the pr…

• FDA approval · 2010-11-12
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2010-10-29
  FDA Approved: DRONABINOL — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for dronabinol from Rhodes Pharmaceuticals L.P., enabling a generic dronabinol product.

• FDA approval · 2010-09-15
  FDA Approved: GRANISETRON HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)

  The FDA has approved a supplemental application for granisetron hydrochloride submitted by Bionpharma Inc., maintaining regulatory approval …

• FDA approval · 2010-06-03
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Parenteral Medicines, Inc.)

  FDA approved a supplemental application for metoclopramide from Teva Parenteral Medicines, Inc., updating the product's approval status as p…

• FDA approval · 2010-04-12
  FDA Approved: ONDANSETRON — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for generic ondansetron by Rising Pharma Holdings, Inc. for prevention of nausea and vomiting in posto…

• FDA approval · 2010-04-09
  FDA Approved: GRANISETRON HYDROCHLORIDE — Original Application (Mylan Institutional LLC)

  FDA approved Mylan Institutional LLC's Original Application for granisetron hydrochloride, a generic version of granisetron. The approval co…

• FDA approval · 2010-04-09
  FDA Approved: GRANISETRON HYDROCHLORIDE — Original Application (Mylan Institutional LLC)

  FDA approved granisetron hydrochloride under an original generic application (ANDA) for preventing nausea and vomiting caused by chemotherap…

• FDA approval · 2010-03-31
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals’ supplemental application for metoclopramide, updating the regulatory status of this generic drug.