CooperSurgical is hit with second letter for misleading promotion of its copper-containing intrauterine contraceptive. Video lacked any safety information, agency says in request for corrective communication.

In its second letter of the year, US Office of Prescription Drug Promotion says Xeris Pharmaceuticals’ television ad fails to include important risk information and misleadingly suggests Gvoke pre-filled syringe can be easily used.

The agency took issue with distracting visuals and reliance on superimposed text in a television spot for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug. This is the third untitled letter from the US FDA to target promotions for women’s health products in the past eighteen months.

‘Untitled’ letter is FDA's third in the past eighteen months to target promotions for women’s health products. In the case of advertisement for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug, the agency took issue with distracting visuals and reliance on superimposed text.