California counties take on hoodia firm
This article was originally published in The Tan Sheet
Executive SummarySolano Superior Court in Santa Cruz, Calif., issues a preliminary injunction against the maker of DEX L-10 Hoodia gordonii weight-loss products, claiming the supplements do not contain hoodia. Local media reports say the injunction would keep Breakthrough Engineered Nutrition Inc. of Seminole, Fla., from selling its products in California. Other counties in the state, including Napa, Orange and Santa Clara, also seek civil penalties against the firm and restitution for consumers, according to the Santa Cruz Sentinel Feb. 2
You may also be interested in...
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.