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Contrave TV Ad's Slimmed Down Adverse Events Draw FDA Rebuke

 
• By Brenda Sandburg

Referencing opioids and suicidal thoughts is not sufficient, US regulators say; letter comes as Orexigen has seen an upsurge in Contrave prescriptions.

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FDA's Office of Prescription Drug Promotion has admonished Orexigen Therapeutics Inc. for failing to include important risk information in a television advertisement for its obesity drug Contrave (naltrexone/bupropion) and for placing other important risk information solely in the visual portion of the promo.

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US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
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