原始来源记录
决策级完整回复函 (CRL)
Aquestive 收到 FDA 关于 Anaphylm NDA 的缺陷通知
FDA 通知 Aquestive，Anaphylm（肾上腺素）舌下膜 NDA 存在缺陷，无法进行标签讨论和上市后承诺。该通知不构成最终决定，审查仍在进行中。公司正努力在 2026 年 1 月 31 日 PDUFA 目标日期前解决问题，但此进展可能导致批准延迟。
关键事实
- 申报时间
- 2026年1月9日 12:18
- 事件
- 完整回复函 (CRL)
- 方向
- 消极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2026年1月31日 · 完整回复函 (CRL)
来源摘录
aqst-20260109 0001398733 false 0001398733 2026-01-09 2026-01-09 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): January 9, 2026 Aquestive Therapeutics, Inc. (Exact name of Registrant as specified in its charter) Delaware 001-38599 82-3827296 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 30 Technology Drive Warren , NJ 07059 ( 908 ) 941-1900 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices) Not Applicable (Former name or former address, if changed since last report) ______________________