Industry Roundup: Prison For Raw Deal Owner, NIH Funds Botanical Research
This article was originally published in The Tan Sheet
Raw Deal owner Barry Steinlight pleads guilty to charge stemming from sales of diluted and adulterated dietary supplements and ingredients; CDER receives requests to extend for a second time the comment period for its review of homeopathic regulation; and more news in brief.
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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.