This article was originally published in The Tan Sheet
Executive SummarySupplement marketer files separate complaints April 24 against Nature's Way, Shaklee, seeking injunctive relief and damages of $30 mil. from each firm. Suit against Nature's Way alleges improper and intentional use of Tishcon's federally registered Staywell trademark on a line of vitamin, nutritional supplements. Complaint against Shaklee challenges firm's "false and misleading" claims for its CoQHeart supplement, including claim it is "up to 333% more bioavailable than other soft gels," which "lacks sufficient scientific support" and harms sales of Tishcon's Q-Gel Coenzyme Q10, suit alleges...
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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.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.