FDA Approves Katerzia

制药公司Azurity首个氨氯地平口服混悬剂Katerzia获美国FDA批准上市

2019-07-11 11:01:00 Drugs

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Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that the U.S. Food and Drug Administration (FDA) has approved Katerzia (amlodipine) Oral Suspension, 1 mg/mL, the first and only FDA-approved amlodipine oral suspension. Katerzia is indicated for the treatment of hypertension (high blood pressure) in adults and pediatric patients 6 years of age and older and coronary artery disease in adults. “We are pleased to announce the FDA approval of Katerzia”, said Neal Muni, MD, MSPH, President and Chief Executive Officer of Azurity Pharmaceuticals. “The addition of Katerzia complements our existing pediatric hypertension portfolio and will strengthen the overall offering from Azurity. It is also our first product approval since CutisPharma and Silvergate Pharmaceuticals came together to make Azurity Pharmaceuticals, making this a truly exciting time.” Katerzia offers a ready-to-use (simply shake) oral suspension for children 6 years of age and older that require or prefer an oral liquid option of amlodipine. Appropriate dosing for children is now simple, safe, and effective, while providing the assurance of quality as an FDA-approved product. Katerzia will be readily available through an extensive network of pharmacies and a qualified mail order service.
Azurity Pharmaceuticals ,一家专门为需要定制护理配方的患者提供安全、优质治疗的专业制药公司,今天宣布美国食品药品监督管理局(Food and Drug Administration)( FDA )已批准卡地亚(氨氯地平)口服混悬剂1毫克/毫升。第一个也是唯一一个 FDA 批准的氨氯地平口服混悬剂。卡地齐亚适用于成人和儿童患者6岁以上的高血压(高血压)和成人冠心病的治疗。 Azurity Pharmaceuticals 总裁兼首席执行官 Neal Muni 医学博士说:“我们很高兴宣布 FDA 批准 Katerzia 。”“ Katerzia的加入补充了我们现有的儿科高血压产品组合,并将加强Azurity的整体产品。这也是我们自 CutisPharma 和 Silvergate Pharmaceuticals 联合生产 Azurity Pharmaceuticals 以来的首次产品批准,使这是一个真正激动人心的时刻。” 卡地亚为6岁及以上需要或更喜欢口服氨氯地平的儿童提供了一种随时可用(简单地摇动)的口服悬浮液。适当的儿童剂量现在是简单,安全和有效的,同时提供质量保证,作为 FDA 批准的产品。Katerzia 将通过广泛的药店网络和合格的邮购服务随时提供。

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