海正药业：子公司制剂产品注射用米卡芬净获得美国FDA批准

Core Viewpoint - The approval of the abbreviated new drug application (ANDA) for injectable micafungin by the U.S. FDA allows the company to produce and sell the product in the U.S. market [1] Group 1: Company Announcement - The company’s wholly-owned subsidiary, Zhejiang Hisun Pharmaceutical Co., Ltd. (referred to as "Hisun Hangzhou"), has received notification from the U.S. FDA regarding the approval of its ANDA for injectable micafungin [1] - This approval signifies a significant milestone for Hisun Hangzhou, enabling it to enter the U.S. market with this product [1] Group 2: Product Indications - Injectable micafungin is indicated for the treatment of: 1. Candidemia, acute disseminated candidiasis, candidal peritonitis, and abscesses in adults and pediatric patients aged 4 months and older 2. Candidemia, acute disseminated candidiasis, candidal peritonitis, and abscesses in pediatric patients under 4 months (without meningitis and/or ocular dissemination) 3. Esophageal candidiasis in adults and pediatric patients aged 4 months and older 4. Prevention of candidal infections in adults and pediatric patients aged 4 months and older following hematopoietic stem cell transplantation [1]