Aquestive's Application for Allergic Reaction Treatment Has Deficiencies, FDA Says

Dow Jones02-02

By Nicholas G. Miller

The Food and Drug Administration sent a complete response letter to Aquestive Therapeutics identifying deficiencies in the application for its Anaphylm Sublingual Film allergic reaction treatment.

The company said the deficiencies were limited to packaging and administration.

"These included instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis," the company said. "To resolve the FDA's concerns, the Company has modified the pouch opening, instructions for use, pouch and carton labeling."

Aquestive said it would resubmit the application as early as the third quarter and that it remained confident in the effectiveness and safety of Anaphylm.

Write to Nicholas G. Miller at nicholas.miller@wsj.com.

(END) Dow Jones Newswires

February 02, 2026 07:22 ET (12:22 GMT)

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Miller \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  The Food and Drug Administration sent a complete response letter to Aquestive <a href=\"https://laohu8.com/S/LENZ\">Therapeutics</a> identifying deficiencies in the application for its Anaphylm Sublingual Film allergic reaction treatment. \n</p>\n<p>\n  The company said the deficiencies were limited to packaging and administration. \n</p>\n<p>\n  \"These included instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis,\" the company said. \"To resolve the FDA's concerns, the Company has modified the pouch opening, instructions for use, pouch and carton labeling.\" \n</p>\n<p>\n  Aquestive said it would resubmit the application as early as the third quarter and that it remained confident in the effectiveness and safety of Anaphylm. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Nicholas G. Miller at nicholas.miller@wsj.com. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  February 02, 2026 07:22 ET (12:22 GMT)\n</p>\n<p>\n  Copyright (c) 2026 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"AQST","symbol_name":"Aquestive Therapeutics Inc.","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2608866715","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2608866715","pubTimestamp":1770034920,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"The Food and Drug Administration sent a complete response letter to Aquestive Therapeutics identifying deficiencies in the application for its Anaphylm Sublingual Film allergic reaction treatment.The company said the deficiencies were limited to packaging and administration.\"These included instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis,\" the company said. \"To resolve the FDA's concerns, the Company has modified the pouch opening, instructions for use, pouch and carton labeling.\". 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Miller \n\n\n \n\n\n  The Food and Drug Administration sent a complete response letter to Aquestive Therapeutics identifying deficiencies in the application for its Anaphylm Sublingual Film allergic reaction treatment. \n\n\n  The company said the deficiencies were limited to packaging and administration. \n\n\n  \"These included instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis,\" the company said. \"To resolve the FDA's concerns, the Company has modified the pouch opening, instructions for use, pouch and carton labeling.\" \n\n\n  Aquestive said it would resubmit the application as early as the third quarter and that it remained confident in the effectiveness and safety of Anaphylm. \n\n\n \n\n\n  Write to Nicholas G. Miller at nicholas.miller@wsj.com. \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  February 02, 2026 07:22 ET (12:22 GMT)\n\n\n  Copyright (c) 2026 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2608866715","isCrawlerRequest":true}