Malaria

• FDA label_change · 2024-10-10
  FDA Approved: SOVUNA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for SOVUNA (hydroxychloroquine sulfate) by ANI Pharmaceuticals, Inc., indicating a label change.

• FDA label_change · 2020-03-31
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Ipca Laboratories Limited, resulting in changes to the drug's la…

• FDA label_change · 2019-11-22
  FDA Approved: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

  FDA supplements the labeling for the atovaquone and proguanil hydrochloride pediatric product, expanding pediatric dosing and indications.

• FDA label_change · 2018-01-08
  FDA Approved: COARTEM — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for COARTEM (artemether and lumefantrine) submitted by Novartis Pharmaceuticals Corporation. The app…

• FDA label_change · 2016-10-11
  FDA Approved: MEFLOQUINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for mefloquine hydrochloride (Teva), indicating changes to the product labeling.

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• FDA label_change · 2014-06-04
  FDA Approved: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

  FDA supplemental approval adds pediatric labeling for atovaquone and proguanil hydrochloride, expanding its use to pediatric patients.

• FDA label_change · 2014-05-06
  FDA Approved: COARTEM — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for COARTEM (artemether and lumefantrine) submitted by Novartis, resulting in changes to the pro…

• FDA label_change · 2012-08-06
  FDA Approved: COARTEM — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for COARTEM (artemether-lumefantrine) from Novartis. This action updates the labeling and/or exp…

• FDA label_change · 2009-09-02
  FDA Approved: MALARONE — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Malarone (atovaquone and proguanil hydrochloride) manufactured by GlaxoSmithKline LLC.

• FDA label_change · 2007-12-04
  FDA Approved: MALARONE — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Malarone to update labeling, including indications for treatment of malaria and prophylaxis agai…