FDA Identifies Deficiencies in Aquestive Anaphylm Review, Approval Pending

Reuters01-09

FDA Identifies Deficiencies in Aquestive Anaphylm Review, Approval Pending

Aquestive Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has identified deficiencies in the company's New Drug Application (NDA) for Anaphylm™ (sublingual epinephrine film), which currently preclude discussions of product labeling and post-marketing commitments. While the FDA's notification did not specify the deficiencies, the agency clarified that its review of the application is ongoing and no final decision has been made. Meanwhile, Aquestive is pursuing regulatory submissions for Anaphylm in Canada, Europe, and the United Kingdom, with plans to submit to Health Canada in the first half of 2026 and to the European Medicines Agency in the second half of 2026. The EMA has indicated that no further clinical trials are required prior to submission.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aquestive Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9622687) on January 09, 2026, and is solely responsible for the information contained therein.

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While the FDA's notification did not specify the deficiencies, the agency clarified that its review of the application is ongoing and no final decision has been made. Meanwhile, Aquestive is pursuing regulatory submissions for Anaphylm in Canada, Europe, and the United Kingdom, with plans to submit to Health Canada in the first half of 2026 and to the European Medicines Agency in the second half of 2026. The EMA has indicated that no further clinical trials are required prior to submission.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aquestive <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9622687) on January 09, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00B3QW5Z07.USD","symbol_name":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260109:nNDL3CWB9h:1","article_id":"2602988378","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2602988378","pubTimestamp":1767960048,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Aquestive Therapeutics Inc. announced that the U.S. Food and Drug Administration  has identified deficiencies in the company's New Drug Application  for Anaphylm , which currently preclude discussions of product labeling and post-marketing commitments. 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While the FDA's notification did not specify the deficiencies, the agency clarified that its review of the application is ongoing and no final decision has been made. Meanwhile, Aquestive is pursuing regulatory submissions for Anaphylm in Canada, Europe, and the United Kingdom, with plans to submit to Health Canada in the first half of 2026 and to the European Medicines Agency in the second half of 2026. The EMA has indicated that no further clinical trials are required prior to submission.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aquestive Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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