Tag: Food and Drug Administration

FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review

Michael Gwarisa

By HealthTimes Reporter The U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. This is the first time the agency has authorized products commonly referred to as nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip. The FDA determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard…

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First Injectable Treatment for HIV Pre-Exposure Prevention Approved

Healthtimes

THE United States (US) Food and Drug Administration approved Apretude or use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug. Own Correspondent “Today’s approval adds an important tool in the effort to…

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