FDA proposes removing oral decongestant phenylephrine from OTC meds

seekingalpha11-08

Joe Raedle/Getty Images News The U.S. FDA is proposing issuing an order that would remove the oral decongestant phenylephrine from many over-the-counter cough and cold medicines as a review has found ...

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The agency said that a comprehensive evaluation examined data from decades ago used to support oral phenylephrine's initial approval as well as newer data. Other formulations of phenylephrine are not impacted.   Oral phenylephrine is found in many popular OTC cough and cold remedies including Kenvue's  Sudafed, Procter & Gamble's  DayQuil and NyQuil, and Haleon's  Robitussin and Triaminic. The FDA's proposed order is not a surprise considering an advisory committee in September 2023 voted that oral phenylephrine lacks effectiveness. 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The agency said that a comprehensive evaluation examined data from decades ago used to support oral phenylephrine's initial approval as well as newer data. Other formulations of phenylephrine are not impacted.   Oral phenylephrine is found in many popular OTC cough and cold remedies including Kenvue's (NYSE:KVUE) Sudafed, Procter & Gamble's (PG) DayQuil and NyQuil, and Haleon's (NYSE:HLN) Robitussin and Triaminic. The FDA's proposed order is not a surprise considering an advisory committee in September 2023 voted that oral phenylephrine lacks effectiveness. The following month, CVS Health (CVS) pulled products containing oral phenylephrine from its shelves.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"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,"deviceId":"web-server-community-laohu8-v3","version":"4.29.2","shortVersion":"4.29.2","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/2481530061"}