Alembic Pharmaceuticals 的仿制药 Icatibant 注射剂获得美国食品药品监督管理局批准，用于治疗遗传性血管性水肿。 Alembic Pharmaceuticals receives USFDA approval for its generic Icatibant injection for treating hereditary angioedema.
Alembic Pharmaceuticals 的仿制药 Icatibant 注射剂获得美国食品药品监督管理局批准，用于治疗成人急性发作的遗传性血管性水肿 (HAE)。 Alembic Pharmaceuticals receives USFDA approval for its generic Icatibant injection, used to treat acute attacks of hereditary angioedema (HAE) in adults. 这是该公司首个获得批准的多肽产品，截至 2024 年 3 月的 12 个月内，该注射剂的预计市场规模为 1.12 亿美元。 This is the company's first peptide product approval and the estimated market size for the injection is $112 million for the 12 months ending Mar 2024. 所获批准的 ANDA 与美国武田制药公司的 Firazyr 注射剂具有治疗等效性。 The approved ANDA is therapeutically equivalent to Takeda Pharmaceuticals U.S.A., Inc.'s Firazyr Injection.