Amphastar Pharmaceuticals 获得 FDA 批准生产硫酸沙丁胺醇吸入气雾剂 (AMP-008)。 Amphastar Pharmaceuticals receives FDA approval for Albuterol Sulfate Inhalation Aerosol (AMP-008).
Amphastar Pharmaceuticals 的硫酸沙丁胺醇吸入气雾剂 (AMP-008) ANDA 获得 FDA 批准，用于治疗/预防 4 岁以上可逆性阻塞性呼吸道疾病患者的支气管痉挛。 Amphastar Pharmaceuticals receives FDA approval for its ANDA of Albuterol Sulfate Inhalation Aerosol (AMP-008), treating/preventing bronchospasm in patients 4+ with reversible obstructive airway disease. FDA 认为它与 Teva Respiratory 的 ProAir® HFA 具有生物等效性。 The FDA considers it bioequivalent to Teva Respiratory's ProAir® HFA. Amphastar 计划于 2024 年第三季度推出，目标产品综合市场规模超过 104 亿美元。 Amphastar plans to launch in Q3 2024, targeting products with combined market sizes of over $10.4B.