苑东生物：亚甲蓝注射液获美国FDA药品注册批准

Core Viewpoint - Yuan Dong Biotech (688513) announced that its wholly-owned subsidiary, Shuo De Pharmaceutical, received formal approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of Methylene Blue Injection, which is indicated for the treatment of acquired methemoglobinemia in both children and adults [1]. Group 1 - The active ingredient of Methylene Blue Injection is Methylene Blue [1]. - The approval of the ANDA marks a significant milestone for the company in the U.S. pharmaceutical market [1]. - The indication for Methylene Blue Injection is specifically for treating acquired methemoglobinemia, a condition affecting both children and adults [1].