Core Viewpoint - Amneal Pharmaceuticals has received FDA approval for Brekiya, the first and only dihydroergotamine autoinjector for the acute treatment of migraines and cluster headaches in adults [1][4]. Product Overview - Brekiya autoinjector offers sustained pain relief in a self-administered format, containing the same medication used in hospitals [2][3]. - The device is easy to use, requiring no refrigeration or assembly, and allows for subcutaneous injection into the thigh [2][3]. - It is designed for patients who may not respond well to oral medications or have conditions that delay treatment [2][4]. Market Context - Approximately 39 million Americans suffer from migraines, with around one million experiencing cluster headaches [4]. - Headaches are a leading cause of emergency room visits, accounting for 3% of all visits in the U.S. [4]. - Brekiya addresses a significant gap in treatment options for cluster headaches, which are often underserved [4]. Company Background - Amneal Pharmaceuticals is a global biopharmaceutical company focused on developing a diverse portfolio of over 280 pharmaceuticals, including injectables and biosimilars [22]. - The company aims to expand its presence in complex product categories and therapeutic areas, particularly in central nervous system and endocrine disorders [22].