VNRs for King's ostensibly abuse-resistant pain drug Embeda drew an FDA warning letter.
The agency said two VNRs omitted or minimized risks, including those featured in the drug's “extensive” boxed warning, and failed to present limitations to the approved indication. Moreover, the letter said King presented misleading claims – among them, about the drug's alleged but clinically unsubstantiated abuse-resistant properties. DDMAC said King agreed to pull the VNRs in August.
DDMAC demanded the company furnish a list of materials it has pulled, and that it disseminate corrective messaging.