Hypoglycemia
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EMA approval · 2026-01-26EMA Authorised: Zegalogue (dasiglucagon hydrochloride) — Zealand Pharma A/S
The EMA has authorised Zegalogue (dasiglucagon hydrochloride) from Zealand Pharma A/S for the emergency treatment of severe hypoglycaemia in…
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EMA approval · 2025-09-17EMA Authorised: Ogluo (Glucagon) — Strongbridge Dublin Limited
EMA has authorised Ogluo, a glucagon medicine from Strongbridge Dublin Limited, for use in diabetes mellitus. The product is approved for em…
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FDA approval · 2025-09-15FDA Approved: GLUCAGON — Original Application (Cipla USA Inc.)
The FDA approved Cipla USA Inc.'s original application for a generic glucagon product, enabling its marketing to treat severe hypoglycemia i…
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FDA approval · 2025-07-30FDA Approved: GLUCAGON — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA has approved a supplemental application for glucagon submitted by Fresenius Kabi USA, LLC. The approval finalizes changes proposed i…
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FDA approval · 2025-07-25FDA Approved: DEXTROSE — Supplemental Application (Hospira, Inc.)
The FDA approved Hospira's supplemental application for DEXTROSE (dextrose monohydrate), resulting in updated labeling and expanded approval…
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FDA approval · 2025-07-22FDA Approved: GLUCAGON — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' generic glucagon injection under an Original Application (ANDA214457). The approval enables Lupin to mar…
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FDA approval · 2025-03-17FDA Approved: BAQSIMI — Supplemental Application (Amphastar Pharmaceuticals, Inc.)
The FDA approved a supplemental application for BAQSIMI (glucagon) from Amphastar Pharmaceuticals, Inc., the nasal glucagon product for emer…
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FDA approval · 2025-03-14FDA Approved: GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR — Supplemental Application (Xeris Pharmaceuticals, Inc.)
FDA approved a supplemental application to add the GVOKE HYPOPEN 0.5 mg auto-injector as a new administration form for glucagon injection so…
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FDA approval · 2024-12-12FDA Approved: GLUCAGON — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved Mylan's original application for a generic glucagon injectable product.
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FDA approval · 2024-07-18FDA Approved: PROGLYCEM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for PROGLYCEM (diazoxide) from Teva Pharmaceuticals USA, Inc. This action updates the product's labe…
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FDA approval · 2023-12-22FDA Approved: GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR — Supplemental Application (Xeris Pharmaceuticals, Inc.)
The FDA approved a supplemental application to add the Gvoke Hypopen 0.5 mg auto-injector for glucagon injection solution. This expands the …
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FDA approval · 2022-12-22FDA Approved: PROGLYCEM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for PROGLYCEM (diazoxide) submitted by Teva Pharmaceuticals USA, Inc., resulting in a label/indicati…
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FDA approval · 2022-07-14FDA Approved: GLUCAGON — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA approved a supplemental application for Glucagon submitted by Fresenius Kabi USA, LLC.
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FDA approval · 2021-08-20FDA Approved: GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR — Supplemental Application (Xeris Pharmaceuticals, Inc.)
FDA approves a supplemental application for GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR, a glucagon injection solution, expanding its device format f…
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FDA approval · 2021-07-29FDA Approved: GLUCAGON — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA approved a supplemental application for the glucagon product from Fresenius Kabi USA, LLC.
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FDA approval · 2020-12-28FDA Approved: GLUCAGON — Original Application (Amphastar Pharmaceuticals, Inc.)
The FDA approved Amphastar Pharmaceuticals' original application for a generic glucagon product to treat severe hypoglycemia in patients wit…
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FDA approval · 2020-04-07FDA Approved: GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR — Supplemental Application (Xeris Pharmaceuticals, Inc.)
The FDA approved a supplemental application for GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR (glucagon injection, solution) from Xeris Pharmaceuticals…
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EMA approval · 2019-10-18First non-injectable treatment for severe low blood sugar levels
EMA announces approval of the first non-injectable treatment for severe hypoglycemia, expanding options for management of severe low blood s…
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FDA approval · 2019-09-10FDA Approved: GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR — Original Application (Xeris Pharmaceuticals, Inc.)
FDA approved GVOKE HYPOPEN 0.5 mg Auto-Injector (glucagon injection, solution) from Xeris Pharmaceuticals in an original application (NDA212…
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FDA approval · 2019-09-09FDA Approved: GLUCAGON — Supplemental Application (Fresenius Kabi USA, LLC)
The FDA approved a supplemental application for GLUCAGON submitted by Fresenius Kabi USA, LLC. The approval updates labeling and/or administ…
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FDA approval · 2019-07-24FDA Approved: BAQSIMI — Original Application (Amphastar Pharmaceuticals, Inc.)
FDA approved BAQSIMI (glucagon) from Amphastar Pharmaceuticals in an Original Application for the treatment of severe hypoglycemia in people…
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FDA approval · 2015-12-01FDA Approved: GLUCAGON — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for Glucagon from Fresenius Kabi USA, LLC.
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FDA approval · 2015-05-08FDA Approved: GLUCAGON — Original Application (Fresenius Kabi USA, LLC)
FDA approved Fresenius Kabi USA, LLC's original application for Glucagon, approving a new source of glucagon for use in treating severe hypo…
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FDA approval · 2013-11-21FDA Approved: PROGLYCEM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental NDA for PROGLYCEM (diazoxide) from Teva Pharmaceuticals USA, expanding or updating its labeling.
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FDA approval · 2008-12-17FDA Approved: PROGLYCEM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for PROGLYCEM (diazoxide) from Teva Pharmaceuticals USA, Inc., indicating an update to the product's…