Takeda Sued In U.S. For Failing To Report Actos Heart-Failure Cases
This article was originally published in PharmAsia News
Takeda Pharmaceutical’s U.S. unit is accused in a whistleblower suit of failing to report hundreds of congestive heart-failure incidents associated with its blockbuster Actos (pioglitazone).
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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.