Malaria
📧 Sign up to get email alerts when something new happens for Malaria.
Sign up freeTop drugs studied for this disease
-
EMA approval · 2026-08-21EMA Authorised: Artesunate Amivas (artesunate) — Amivas Ireland Ltd
The EMA authorises Artesunate Amivas (artesunate) for malaria, with Amivas Ireland Ltd as the marketing authorization holder, classified as …
-
EMA approval · 2026-03-24EMA Authorised: Artesunate Amivas (artesunate) — Amivas Ireland Ltd
The European Medicines Agency authorised Artesunate Amivas (artesunate) for malaria, with orphan designation and marketing authorization gra…
-
FDA approval · 2026-03-23FDA Approved: MALARONE — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for Malarone (atovaquone and proguanil hydrochloride) from GlaxoSmithKline LLC.
-
FDA approval · 2026-02-02FDA 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.
-
EMA approval · 2025-09-04EMA Authorised: Eurartesim (piperaquine tetraphosphate;artenimol) — Alfasigma S.p.A.
The EMA has authorised Eurartesim for malaria treatment in the European Union. The product combines piperaquine tetraphosphate and artenimol…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2025-08-18FDA Approved: PRIMAQUINE PHOSPHATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental application for Primaquine Phosphate by Unichem Pharmaceuticals (USA), Inc., granting marketing authorization fo…
-
FDA approval · 2025-06-13FDA Approved: HYDROXYCHLOROQUINE — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for hydroxychloroquine (HYDROXYCHLOROQUINE) from Chartwell RX, LLC under an ANDA. The action upd…
-
FDA approval · 2025-03-31FDA Approved: DOXYCYCLINE — Supplemental Application (Par Health USA, LLC)
The FDA approved a supplemental application for doxycycline from Par Health USA, LLC under an ANDA, authorizing changes to the generic produ…
-
FDA approval · 2024-12-04FDA Approved: DOXYCYCLINE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's generic doxycycline as an original ANDA product.
-
FDA approval · 2024-10-11FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for hydroxychloroquine sulfate submitted by Aurobindo Pharma Limited.
-
FDA approval · 2024-05-20FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for hydroxychloroquine sulfate from Amneal Pharmaceuticals NY LLC.
-
FDA approval · 2024-04-02FDA Approved: ATOVAQUONE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' supplemental application for atovaquone.
-
FDA approval · 2024-02-02FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for CHLOROQUINE PHOSPHATE from Amneal Pharmaceuticals of New York LLC. This action approves changes …
-
FDA approval · 2024-01-24FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Ipca Laboratories Limited)
FDA approved a supplemental application for hydroxychloroquine sulfate manufactured by Ipca Laboratories Limited. The approval updates the p…
-
FDA approval · 2023-11-29FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for HYDROXYCHLOROQUINE SULFATE from Dr. Reddy's Laboratories Inc.
-
FDA approval · 2023-09-14FDA Approved: SOVUNA — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for SOVUNA (hydroxychloroquine sulfate) submitted by ANI Pharmaceuticals, under NDA 214581.
-
FDA approval · 2023-07-24FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for CHLOROQUINE PHOSPHATE filed by Rising Pharma Holdings, Inc. under ANDA 091621.
-
FDA approval · 2023-07-24FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for chloroquine phosphate from Amneal Pharmaceuticals of New York LLC, approving the generic product…
-
FDA approval · 2023-07-24FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Suven Pharmaceuticals Limited)
FDA approved Suven Pharmaceuticals Limited's supplemental application for chloroquine phosphate under ANDA214756. This approval enables the …
-
FDA approval · 2023-06-12FDA Approved: PRIMAQUINE PHOSPHATE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
The FDA approved a supplemental application for Primaquine Phosphate from Ingenus Pharmaceuticals, LLC under an ANDA, enabling the generic p…
-
FDA approval · 2023-05-05FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for hydroxychloroquine sulfate from Sun Pharmaceutical Industries, Inc., updating the approval for t…
-
FDA approval · 2023-03-30FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for hydroxychloroquine sulfate filed by Teva Pharmaceuticals USA, Inc., marking an approved change u…
-
FDA approval · 2023-03-10FDA Approved: CHLOROQUINE PHOSPHATE — Supplemental Application (Suven Pharmaceuticals Limited)
FDA approved a supplemental application for chloroquine phosphate from Suven Pharmaceuticals Limited, enabling the availability of a generic…
-
FDA approval · 2023-02-27FDA Approved: PRIMAQUINE PHOSPHATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approves a supplemental application for Primaquine Phosphate by Unichem Pharmaceuticals (USA), expanding the approved product's use/labe…
-
FDA approval · 2022-12-07FDA Approved: DOXYCYCLINE — Original Application (Par Health USA, LLC)
FDA approved a generic doxycycline product under an original new drug application by Par Health USA, LLC (ANDA216690).