FDA批准了Amphastar用于高风险骨质疏松的仿制特里帕肽笔，预计年底上市。 FDA approves Amphastar’s generic teriparatide pen for high-risk osteoporosis, launching year-end.

美国食品和药物管理局批准了Amphastar Pharmaceuticals通用皮剂注射,这是一种预填充的笔配方,用于治疗绝经后妇女的高风险骨质疏松症,男性的初级或下骨质疏松症,以及那些有葡萄糖皮质激素诱导的骨质疏松症. The FDA has approved Amphastar Pharmaceuticals’ generic teriparatide injection, a prefilled pen formulation for treating high-risk osteoporosis in postmenopausal women, men with primary or hypogonadal osteoporosis, and those with glucocorticoid-induced osteoporosis. 该药与Eli Lilly的FORTEO具有生物等效性, 在美国制造, 将在年底推出, 提供成本低、方便用户的选择。 The drug, bioequivalent to Eli Lilly’s FORTEO®, is manufactured in the U.S. and will launch by year-end, offering a lower-cost, user-friendly option. 过去一年美国teriparatide销售额为5.85亿美元，Amphastar的参赛支持了国内供应的韧性。 With U.S. teriparatide sales at $585 million over the past year, Amphastar’s entry supports domestic supply resilience. 该公司在以70亿美元以上的市场为目标的发展方面也拥有多个ANDAs和生物类别,还有新的注射疗法和内科疗法。 The company also has multiple ANDAs and biosimilars in development targeting markets exceeding $7 billion, along with novel injectable and intranasal therapies in progress.