Postoperative Nausea and Vomiting

• FDA approval · 2021-08-19
  FDA Approved: ONDANSETRON — Supplemental Application (Eugia US LLC)

  FDA approves a supplemental application for ondansetron hydrochloride (Ondansetron) submitted by Eugia US LLC.

• FDA approval · 2021-08-16
  FDA Approved: ONDANSETRON — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for ondansetron by Hikma Pharmaceuticals USA Inc., confirming the continued availability/approval of…

• FDA approval · 2021-06-29
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Original Application (Avenacy, Inc.)

  FDA approved palonosetron hydrochloride under an Original Abbreviated New Drug Application for Avenacy, Inc.

• FDA approval · 2021-05-25
  FDA Approved: BARHEMSYS — Supplemental Application (Acacia Pharma Ltd)

  The FDA approved a supplemental application for BARHEMSYS (amisulpride) submitted by Acacia Pharma Ltd.

• FDA approval · 2020-12-23
  FDA Approved: APREPITANT — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for aprepitant submitted by Sandoz Inc.

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• FDA approval · 2020-10-21
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for palonosetron hydrochloride by Sandoz Inc under ANDA 202521. The approval confirms the generic pr…

• FDA approval · 2020-10-21
  FDA Approved: APREPITANT — Original Application (Golden State Medical Supply, Inc.)

  FDA approved the original application for aprepitant, granting a generic version of this antiemetic to expand access.

• FDA approval · 2020-09-08
  FDA Approved: FOSAPREPITANT DIMEGLUMINE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved fosaprepitant dimeglumine from Hikma as a generic injectable antiemetic to prevent chemotherapy- and postoperative-induced naus…

• FDA approval · 2020-09-01
  FDA Approved: BARHEMSYS — Supplemental Application (Acacia Pharma Ltd)

  FDA approved a supplemental application for BARHEMSYS (amisulpride) submitted by Acacia Pharma Ltd.

• FDA approval · 2020-06-25
  FDA Approved: PROCHLORPERAZINE EDISYLATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Prochlorperazine Edisylate from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals).

• FDA approval · 2020-04-01
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for palonosetron hydrochloride from Cipla USA Inc.

• FDA approval · 2020-02-26
  FDA Approved: BARHEMSYS — Original Application (Acacia Pharma Ltd)

  The FDA approved BARHEMSYS (amisulpride) via the Original Application for the prevention of postoperative nausea and vomiting in adults, mar…

• FDA approval · 2019-11-14
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for EMEND (aprepitant) from Merck Sharp & Dohme LLC to expand its approved use as an antiemetic for …

• FDA approval · 2019-11-14
  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 · 2019-10-30
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for metoclopramide hydrochloride from Fresenius Kabi USA, LLC.

• FDA approval · 2019-10-29
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for palonosetron hydrochloride from Sandoz Inc, authorizing changes under the ANDA pathway.

• FDA approval · 2019-09-25
  FDA Approved: EMEND — Supplemental Application (Merck Sharp & Dohme LLC)

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

• FDA approval · 2019-07-16
  FDA Approved: METOCLOPRAMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for metoclopramide, a generic, indicating an updated or additional labeling under an approved A…

• FDA approval · 2019-06-19
  FDA Approved: SCOPOLAMINE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan's original Abbreviated New Drug Application for scopolamine, enabling a generic version of the product.

• FDA approval · 2019-05-24
  FDA Approved: METOCLOPRAMIDE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for metoclopramide hydrochloride, authorizing an updated approval for this …

• FDA approval · 2019-03-01
  FDA Approved: TRANSDERM SCOP — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application for Transderm Scop (scopolamine) by Baxter Healthcare Corporation, updating the product's approv…

• FDA approval · 2018-11-06
  FDA Approved: PALONOSETRON HYDROCHLORIDE — Original Application (Eugia US LLC)

  The FDA approved Eugia US LLC's original application for palonosetron hydrochloride (generic) to prevent chemotherapy- and postoperative-ind…

• FDA approval · 2018-10-25
  FDA Approved: PROCHLORPERAZINE EDISYLATE — Original Application (Mylan Institutional LLC)

  The FDA approved the original ANDA for Prochlorperazine Edisylate by Mylan Institutional LLC, enabling a generic version of this antiemetic.…

• FDA approval · 2018-09-19
  FDA Approved: PALONOSETRON — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA, LLC's original application for Palonosetron, a generic antiemetic, for the prevention of chemotherapy- and …

• FDA approval · 2018-09-19
  FDA Approved: PALONOSETRON — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's original application for Palonosetron, a 5-HT3 receptor antagonist used to prevent chemotherapy-i…