Acute Promyelocytic Leukemia
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-04-21EMA Authorised: Arsenic trioxide medac (arsenic trioxide) — medac Gesellschaft für klinische Spezialpräparate mbH
EMA authorised Arsenic trioxide medac for the treatment of acute promyelocytic leukemia.
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EMA approval · 2026-03-13EMA Authorised: Arsenic trioxide Accord (arsenic trioxide) — Accord Healthcare S.L.U.
The European Medicines Agency authorised Arsenic trioxide Accord for the treatment of acute promyelocytic leukemia.
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EMA approval · 2026-01-30EMA Authorised: Trisenox (arsenic trioxide) — Teva B.V.
The European Medicines Agency has authorised Trisenox (arsenic trioxide) by Teva B.V. for use in acute promyelocytic leukemia.
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FDA approval · 2026-01-30FDA Approved: ARSENIC TRIOXIDE — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for arsenic trioxide from Eugia US LLC under an ANDA. This action updates regulatory details for…
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FDA approval · 2025-03-03FDA Approved: TRETINOIN — Original Application (Encube Ethicals, Inc.)
The FDA approved Encube Ethicals’ original application for tretinoin, granting a generic version of the dermatology retinoid. This marks a f…
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FDA approval · 2025-01-29FDA Approved: TRETINOIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approves Glenmark's supplemental application for tretinoin (all-trans retinoic acid), updating the product's regulatory status per the s…
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FDA approval · 2025-01-13FDA Approved: TRETINOIN — Original Application (Aurobindo Pharma Limited)
FDA approved an Original Application for tretinoin from Aurobindo Pharma Limited, making a generic version of tretinoin available. This is a…
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FDA approval · 2024-07-08FDA Approved: ARSENIC TRIOXIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for arsenic trioxide from Zydus Pharmaceuticals USA Inc. under ANDA206228.
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FDA approval · 2024-06-10FDA Approved: TRETINOIN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's supplemental application for tretinoin (generic) under ANDA 208279, authorizing continued or expanded marketing of t…
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FDA approval · 2023-10-11FDA Approved: ARSENIC TRIOXIDE — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA approved a supplemental application for arsenic trioxide submitted by Fresenius Kabi USA, LLC under an existing ANDA.
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FDA approval · 2023-08-22FDA Approved: TRETINOIN — Original Application (Encube Ethicals, Inc.)
FDA approved the original application for tretinoin from Encube Ethicals, Inc., enabling a generic version of tretinoin.
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FDA approval · 2023-04-20FDA Approved: ARSENIC TRIOXIDE — Original Application (Northstar Rx LLC)
Original application approval of Arsenic Trioxide (generic) by Northstar Rx LLC.
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FDA approval · 2021-12-02FDA Approved: ARSENIC TRIOXIDE — Original Application (Sandoz Inc)
FDA approved the original application for arsenic trioxide from Sandoz Inc., enabling the generic version to reach the market.
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FDA approval · 2021-11-12FDA Approved: ARSENIC TRIOXIDE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
The FDA approved a supplemental application for arsenic trioxide from Ingenus Pharmaceuticals, LLC.
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FDA approval · 2021-10-15FDA Approved: ARSENIC TRIOXIDE — Original Application (Eugia US LLC)
FDA approved a generic arsenic trioxide product (Eugia US LLC) under an original ANDA. The approval supports use for acute promyelocytic leu…
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FDA approval · 2021-10-07FDA Approved: ARSENIC TRIOXIDE — Original Application (Sagent Pharmaceuticals)
FDA approved the Original Application (ANDA) for arsenic trioxide from Sagent Pharmaceuticals, enabling a generic version of the cancer drug…
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FDA approval · 2021-01-25FDA Approved: ARSENIC TRIOXIDE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' arsenic trioxide as an original ANDA, providing a generic injectable for acute promyelocytic leukemia.
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FDA approval · 2020-10-20FDA Approved: TRISENOX — Supplemental Application (Cephalon, LLC)
The FDA approved a supplemental application for Trisenox (arsenic trioxide) submitted by Cephalon, LLC.
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FDA approval · 2020-05-15FDA Approved: ARSENIC TRIOXIDE — Supplemental Application (Ingenus Pharmaceuticals, LLC)
FDA approved a supplemental application for arsenic trioxide from Ingenus Pharmaceuticals, LLC, enabling its generic product to be marketed …
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FDA approval · 2019-06-20FDA Approved: TRISENOX — Supplemental Application (Cephalon, LLC)
FDA approved a supplemental application for TRISENOX (arsenic trioxide) submitted by Cephalon, LLC.
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FDA approval · 2018-11-15FDA Approved: ARSENIC TRIOXIDE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved the original ANDA for arsenic trioxide, marketed by Ingenus Pharmaceuticals, LLC. This approval provides generic access to arse…
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FDA approval · 2018-11-15FDA Approved: ARSENIC TRIOXIDE — Original Application (Nexus Pharmaceuticals LLC)
FDA approved Nexus Pharmaceuticals LLC's generic arsenic trioxide under ANDA209780.
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FDA approval · 2018-11-13FDA Approved: ARSENIC TRIOXIDE — Original Application (Nordic Pharma, Inc.)
The FDA approved the original application for a generic arsenic trioxide product from Nordic Pharma, Inc.
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FDA approval · 2018-11-13FDA Approved: ARSENIC TRIOXIDE — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approves the original ANDA for arsenic trioxide from Zydus Pharmaceuticals USA Inc., allowing a generic version of the cancer therapy to…
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FDA approval · 2018-08-31FDA Approved: ARSENIC TRIOXIDE — Original Application (Fresenius Kabi USA, LLC)
FDA approved Fresenius Kabi USA, LLC's original application for arsenic trioxide, enabling its marketing as a generic product in the United …