Hereditary Angioedema
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-07-18FDA Approved: ICATIBANT — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for ICATIBANT submitted by Teva Pharmaceuticals USA, Inc. This action relates to a supplemental …
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FDA approval · 2024-06-14FDA Approved: ICATIBANT — Original Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic Pharmaceuticals Limited's generic icatibant (ANDA213773) for the treatment of acute attacks of hereditary angioedema.
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FDA approval · 2024-01-19FDA Approved: FIRAZYR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for FIRAZYR (icatibant acetate) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2023-11-21FDA Approved: ORLADEYO — Supplemental Application (BioCryst Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ORLADEYO (berotralstat hydrochloride) from BioCryst Pharmaceuticals.
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FDA approval · 2023-08-14FDA Approved: ICATIBANT — Original Application (Eugia US LLC)
FDA approves the original ANDA for icatibant (generic) by Eugia US LLC for the treatment of acute hereditary angioedema attacks.
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FDA approval · 2023-07-24FDA Approved: SAJAZIR — Supplemental Application (Cycle Pharmaceuticals Ltd-Uk)
SAJAZIR (icatibant) received FDA approval of a supplemental application filed by Cycle Pharmaceuticals Ltd-Uk.
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FDA approval · 2023-02-03FDA Approved: TAKHZYRO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for TAKHZYRO (lanadelumab-flyo) from Takeda Pharmaceuticals America, Inc., to update and expand …
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FDA approval · 2022-04-28FDA Approved: FIRAZYR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for FirazyR (icatibant acetate) submitted by Takeda Pharmaceuticals America, Inc. The approval u…
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FDA approval · 2022-02-08FDA Approved: TAKHZYRO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved TAKHZYRO (lanadelumab-flyo) via a supplemental application from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2021-06-03FDA Approved: SAJAZIR — Supplemental Application (Cycle Pharmaceuticals Ltd-Uk)
FDA approved a supplemental application for SAJAZIR (icatibant) from Cycle Pharmaceuticals Ltd-Uk. This approval supports a generic icatiban…
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FDA approval · 2020-12-28FDA Approved: KALBITOR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Kalbitor (ecallantide) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2020-12-03FDA Approved: ORLADEYO — Original Application (BioCryst Pharmaceuticals, Inc.)
The FDA approved ORLADEYO (berotralstat hydrochloride) from BioCryst Pharmaceuticals via an original application for prophylaxis to prevent …
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FDA approval · 2020-09-25FDA Approved: ICATIBANT — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for icatibant from Teva Pharmaceuticals USA, Inc. The action updates or adds to the existing labelin…
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FDA approval · 2020-09-25FDA Approved: ICATIBANT — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for ICATIBANT submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2020-07-13FDA Approved: SAJAZIR — Original Application (Cycle Pharmaceuticals Ltd-Uk)
FDA approved SAJAZIR (icatibant) under an original ANDA from Cycle Pharmaceuticals Ltd-Uk, establishing a generic icatibant option for treat…
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FDA approval · 2020-06-18FDA Approved: ICATIBANT — Original Application (Fresenius Kabi USA, LLC)
FDA approved Fresenius Kabi USA, LLC's generic icatibant (ANDA 208317) for the treatment of acute attacks of hereditary angioedema.
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FDA approval · 2020-04-16FDA Approved: FIRAZYR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for FIRAZYR (icatibant acetate) submitted by Takeda Pharmaceuticals America, Inc. This action consti…
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FDA approval · 2020-03-09FDA Approved: ICATIBANT — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma's generic icatibant under ANDA211021 for the treatment of acute attacks of hereditary angioedema.
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FDA approval · 2019-07-15FDA Approved: ICATIBANT — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's original application for icatibant, a generic formulation for the treatment of acute attacks of hereditary angioedema.
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EMA approval · 2018-10-19New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin
EMA announces a new medicine for hereditary angioedema, a rare disorder characterized by swelling beneath the skin.
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FDA approval · 2018-08-23FDA Approved: TAKHZYRO — Original Application (Takeda Pharmaceuticals America, Inc.)
FDA approved TAKHZYRO (lanadelumab-flyo) from its original application for the prevention of attacks in patients with hereditary angioedema.
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FDA approval · 2016-01-25FDA Approved: FIRAZYR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for FIRAZYR (icatibant acetate) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2015-11-24FDA Approved: FIRAZYR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for FIRAZYR (icatibant acetate) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2015-08-10FDA Approved: FIRAZYR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for FIRAZYR (icatibant acetate) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2014-09-08FDA Approved: KALBITOR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Kalbitor (ecallantide) submitted by Takeda Pharmaceuticals America, resulting in updated labelin…