Malaria

• FDA approval · 2019-02-22
  FDA Approved: MALARONE — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Malarone, a combination of atovaquone and proguanil hydrochloride, from GlaxoSmithKline LLC.

• FDA approval · 2019-01-15
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved a generic hydroxychloroquine sulfate product under an Original Application from Rising Pharma Holdings, Inc. for use in tre…

• FDA approval · 2018-11-21
  FDA Approved: ATOVAQUONE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved the original application for atovaquone as a generic drug, confirming its approved uses for Pneumocystis jirovecii pneumonia, p…

• FDA approval · 2018-08-08
  FDA Approved: ARAKODA — Original Application (60 Degrees Pharmaceuticals, INC.)

  FDA approved ARAKODA (tafenoquine) through an original application from 60 Degrees Pharmaceuticals for malaria prevention in adults.

• FDA approval · 2018-07-06
  FDA Approved: HYDROXYCHLOROQUINE — Original Application (Chartwell RX, LLC)

  FDA approved an original application for a generic hydroxychloroquine product (ANDA210543) developed by Chartwell RX, LLC.

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• FDA approval · 2018-05-15
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a generic hydroxychloroquine sulfate product from Amneal Pharmaceuticals NY LLC under an original application.

• FDA approval · 2018-05-08
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved hydroxychloroquine sulfate as a generic drug under an Original Application (ANDA201691) for Sun Pharmaceutical Industries, Inc.

• FDA approval · 2018-05-01
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original ANDA for hydroxychloroquine sulfate (generic) from Dr. Reddy's Laboratories Inc. This approval authorizes marketin…

• FDA approval · 2017-06-22
  FDA Approved: PRIMAQUINE PHOSPHATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Primaquine Phosphate, approving an update to the product's regulatory status. The product is use…

• FDA approval · 2017-06-21
  FDA Approved: PYRIMETHAMINE — Supplemental Application (OAKRUM PHARMA, LLC)

  FDA approved a supplemental NDA for Pyrimethamine submitted by Oakrum Pharma, LLC.

• FDA approval · 2017-01-27
  FDA Approved: PLAQUENIL — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for Plaquenil (hydroxychloroquine sulfate) from Advanz Pharma (US) Corp.

• FDA approval · 2016-10-11
  FDA Approved: MEFLOQUINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for generic mefloquine hydrochloride from Chartwell RX, LLC.

• FDA approval · 2016-07-27
  FDA Approved: PRIMAQUINE PHOSPHATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for primaquine phosphate filed by Sanofi-Aventis U.S. LLC.

• FDA approval · 2016-06-23
  FDA Approved: PRIMAQUINE PHOSPHATE — Original Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved Ingenus Pharmaceuticals’ original application for primaquine phosphate, a generic antimalarial, to bring this product to ma…

• FDA approval · 2016-06-01
  FDA Approved: COARTEM — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for COARTEM (artemether and lumefantrine) from Novartis Pharmaceuticals Corporation. The action expa…

• FDA approval · 2016-01-06
  FDA Approved: COARTEM — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for COARTEM (artemether and lumefantrine) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2015-12-17
  FDA Approved: QUININE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Quinine Sulfate from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2015-09-21
  FDA Approved: DOXYCYCLINE HYCLATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Doxycycline Hyclate by Hikma Pharmaceuticals USA Inc., indicating a change to the product's labe…

• FDA approval · 2015-09-02
  FDA Approved: COARTEM — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• EMA approval · 2015-07-24
  First malaria vaccine receives positive scientific opinion from EMA

  EMA issued a positive scientific opinion on the first malaria vaccine, indicating potential approval and use in malaria prevention.

• FDA approval · 2015-07-22
  FDA Approved: QUININE SULFATE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a quinine sulfate generic under ANDA 204372 from Ingenus Pharmaceuticals, LLC, for use in treating malaria.

• FDA approval · 2015-07-15
  FDA Approved: QUININE SULFATE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's Quinine Sulfate Original Application, making a generic quinine sulfate product available. The product is indicated for…

• FDA approval · 2015-04-16
  FDA Approved: PRIMAQUINE PHOSPHATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Primaquine phosphate submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2015-01-20
  FDA Approved: COARTEM — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for COARTEM (artemether and lumefantrine) from Novartis Pharmaceuticals Corporation to update labeli…

• FDA approval · 2015-01-20
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for hydroxychloroquine sulfate submitted by Aurobindo Pharma Limited.