Herpes Claim Emerges As Latest FDA/FTC Joint Enforcement Target
This article was originally published in The Tan Sheet
Strictly Health Corp. makes claims on its websites and in social media postings for its dietary supplements including, “incredible remedy is an advanced and multifaceted herpes treatment that overwhelms and keeps the virus sealed and subdued.”
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FTC joins FDA in one of the three warning letters to firms claiming their products can either prevent or treat Ebola. One firm’s website offers a video titled, “Urgent Message to Ebola-Stricken Nations' Heads of State,” and another claims “primary uses for oregano include athlete’s foot, candida, canker sores, Ebola virus.”
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.