Aquestive Therapeutics Announces DA Feedback And Reaffirms NDA Submission Guidance For Anaphylm Sublingual Film; Confirms No Additional Adult Clinical Trials Are Necessary Prior To NDA Submission
Aquestive Therapeutics Announces DA Feedback And Reaffirms NDA Submission Guidance For Anaphylm Sublingual Film; Confirms No Additional Adult Clinical Trials Are Necessary Prior To NDA Submission
- Reaffirms New Drug Application (NDA) first quarter 2025 submission guidance
- Confirms no additional adult clinical trials are necessary prior to NDA submission
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Commenced pediatric trial in the U.S. and Canada
- 2025年第一季度提交新藥申請(NDA)的指導意見再次確認
- 確認在提交新藥申請(NDA)之前不需要進行額外的成人臨床試驗
- 在美國和加拿大啓動了兒童試驗
WARREN, N.J., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies ("Aquestive," the "Company" or "we"), today announced receipt of positive feedback from the U.S. Food and Drug Administration (FDA) prior to its planned NDA submission for Anaphylm (epinephrine) Sublingual Film. Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis, if approved by the FDA.
納斯達克:Aquestive Therapeutics, Inc.(NASDAQ:AQST)是一家藥品公司，通過創新科學和傳遞技術推進藥物，爲患者的生活帶來有意義的改善("Aquestive," "公司"或"我們")。今天宣佈美國食品和藥物管理局(FDA)在其計劃的用於Anaphylm(腎上腺素)舌下薄膜的NDA提交前收到積極反饋。 如果獲得FDA批准，Anaphylm有可能成爲用於治療嚴重過敏反應，包括過敏性休克的第一款也是唯一一款口服腎上腺素產品。
