Anaphylaxis
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EMA approval · 2026-04-07EMA Authorised: Eurneffy (epinephrine) — ALK-Abelló A/S
EMA authorised Eurneffy for the treatment of anaphylaxis; the marketing authorisation holder is ALK-Abelló A/S.
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FDA approval · 2026-03-30FDA Approved: EPINEPHRINE — Original Application (Baxter Healthcare Corporation)
FDA approved Baxter's Original Application for EPINEPHRINE, enabling the marketing of an epinephrine product. The approval covers emergency …
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FDA approval · 2026-03-26FDA Approved: NEFFY — Supplemental Application (ARS Pharmaceuticals Operations, Inc.)
FDA approved a supplemental NDA for NEFFY (epinephrine) from ARS Pharmaceuticals Operations, Inc., expanding its use for emergency treatment…
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FDA approval · 2025-12-08FDA Approved: EPINEPHRINE — Original Application (Amneal Pharmaceuticals Private Limited)
The FDA approved Amneal Pharmaceuticals' generic Epinephrine product under an Original Application (ANDA), authorizing its marketing.
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FDA approval · 2025-10-24FDA Approved: NEFFY — Supplemental Application (ARS Pharmaceuticals Operations, Inc.)
FDA approves a supplemental application for NEFFY (epinephrine) by ARS Pharmaceuticals Operations, Inc., authorizing changes to the product'…
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FDA approval · 2025-10-14FDA Approved: EPINEPHRINE — Original Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal Pharmaceuticals' original application for a generic epinephrine product.
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FDA approval · 2025-06-30FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)
FDA approved a supplemental application for epinephrine from BPI Labs, LLC, confirming regulatory action on the product.
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FDA approval · 2025-06-03FDA Approved: EPINEPHRINE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)
FDA approves Glenmark's generic epinephrine injection under Original Application (ANDA 218144), enabling its marketing in the United States.…
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FDA approval · 2025-03-13FDA Approved: EPINEPHRINE — Original Application (Fresenius Kabi USA, LLC)
The FDA approved an Epinephrine product under Fresenius Kabi USA, LLC's Original Application. This marks the product's clearance for marketi…
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FDA approval · 2025-03-05FDA Approved: NEFFY — Supplemental Application (ARS Pharmaceuticals Operations, Inc.)
The FDA approved a supplemental application for NEFFY (epinephrine) from ARS Pharmaceuticals Operations, Inc. The approval updates the produ…
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FDA approval · 2025-02-28FDA Approved: EPINEPHRINE — Original Application (Baxter Healthcare Corporation)
FDA approved the original application for epinephrine by Baxter Healthcare Corporation. Epinephrine is used in emergencies for severe allerg…
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FDA approval · 2025-02-28FDA Approved: EPINEPHRINE — Supplemental Application (American Regent, Inc.)
FDA approved a supplemental application for EPINEPHRINE from American Regent, Inc., indicating an approved change to the product's labeling …
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FDA approval · 2024-08-09FDA Approved: NEFFY — Original Application (ARS Pharmaceuticals Operations, Inc.)
The FDA approved NEFFY (epinephrine) from ARS Pharmaceuticals in an original application for the treatment of anaphylaxis.
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EMA approval · 2024-06-28First nasal adrenaline spray for emergency treatment against allergic reactions
The European Medicines Agency approved the first nasal spray formulation of epinephrine for emergency treatment of allergic reactions, provi…
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FDA approval · 2023-12-28FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)
The FDA has approved a supplemental application for epinephrine filed by BPI Labs, LLC under the existing NDA. The approval authorizes chang…
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FDA approval · 2023-10-19FDA Approved: ADRENALIN (EPINEPHRINE IN SODIUM CHLORIDE) — Supplemental Application (Par Health USA, LLC)
The FDA approved a supplemental application for Adrenalin (epinephrine in sodium chloride) from Par Health USA, LLC, enabling continued mark…
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FDA approval · 2023-05-12FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)
FDA approved a supplemental application for Epinephrine from BPI Labs, LLC. This marks an additional regulatory authorization for Epinephrin…
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FDA approval · 2023-04-21FDA Approved: ADRENALIN (EPINEPHRINE IN SODIUM CHLORIDE) — Original Application (Par Health USA, LLC)
FDA approves Adrenalin, a formulation of epinephrine in sodium chloride, under the original application submitted by Par Health USA, LLC. Th…
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FDA approval · 2023-02-10FDA Approved: EPIPEN — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for EPIPEN (epinephrine auto-injector) filed by Viatris Specialty LLC.
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FDA approval · 2022-08-15FDA Approved: EPINEPHRINE — Original Application (International Medication Systems, Limited)
FDA approved a new epinephrine product under Original Application NDA211363 from International Medication Systems, Limited.
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FDA approval · 2020-12-24FDA Approved: EPIPEN — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for EPIPEN (epinephrine) filed by Viatris Specialty LLC.
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FDA approval · 2020-06-17FDA Approved: EPIPEN — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Epipen (epinephrine auto-injector) from Viatris Specialty LLC. The approval covers changes appro…
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FDA approval · 2020-04-24FDA Approved: EPINEPHRINE — Original Application (International Medication Systems, Limited)
FDA approves the original application for a generic epinephrine product from International Medication Systems, Limited (ANDA211880). The pro…
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FDA approval · 2020-01-31FDA Approved: EPIPEN — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for EPIPEN (epinephrine auto-injector) from Viatris Specialty LLC.
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FDA approval · 2019-09-28FDA Approved: AUVI-Q — Supplemental Application (kaleo, Inc)
The FDA approved a supplemental application for AUVI-Q (epinephrine) filed by Kaleo, Inc.