Plasmodium Vivax Malaria

• FDA approval · 2026-02-02
  FDA Approved: PRIMAQUINE PHOSPHATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Primaquine Phosphate from Sanofi-Aventis U.S. LLC, leading to a labeling update for the product.

• FDA approval · 2022-02-25
  FDA Approved: ARAKODA — Supplemental Application (60 Degrees Pharmaceuticals, INC.)

  The FDA approved a supplemental application for ARAKODA (tafenoquine) by 60 Degrees Pharmaceuticals, expanding the medication’s labeling/ind…

• FDA approval · 2020-11-16
  FDA Approved: KRINTAFEL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Krintafel (tafenoquine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2018-07-20
  FDA Approved: KRINTAFEL — Original Application (GlaxoSmithKline LLC)

  FDA approves Krintafel (tafenoquine succinate) from GlaxoSmithKline LLC through an original application for the radical cure of Plasmodium v…

• FDA approval · 2013-04-03
  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…

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