FDA因包装和使用问题推迟批准Aquestive的肾上腺素薄膜，但无安全隐患。 FDA delays approval of Aquestive's epinephrine film due to packaging and use issues, but no safety concerns.

FDA对其Anaphylm舌下肾上腺素薄膜的Aquestive Therapeutics发布了《全面回应信》，指出人为因素问题，如打开袋子困难和紧急情况下放置不当的薄膜，但未发现安全性、有效性或制造问题。 The FDA issued a Complete Response Letter to Aquestive Therapeutics for its Anaphylm sublingual epinephrine film, citing human factors issues like difficulty opening the pouch and incorrect film placement during emergencies, but found no safety, efficacy, or manufacturing concerns. 该公司将修改包装和标签,进行新的人的因素研究和有针对性的药理动力学研究,并计划在Q3 2026中重新提交申请,以便进行快速审查。 The company will revise packaging and labeling, conduct a new human factors study and a targeted pharmacokinetic study, and plans to resubmit the application in Q3 2026, aiming for a rapid review. 加拿大、欧洲和联合王国正在逐步提交国际监管呈件。 International regulatory submissions are progressing in Canada, Europe, and the UK.