More Import Seizures Yield Spiked Supplements
This article was originally published in The Tan Sheet
Seized products branded as Viagra 007, King of Romance and Black Panther contained sildenafil, the active ingredient in the Rx ED drug Viagra; and products branded Li Da Dai Dai Hua and Slim Forte contained the banned weight-loss drug ingredient sibutramine.
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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.