King warned on Embeda VNRs
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 warning letter said King presented misleading claims – among them, those about the drug's alleged abuse-resistant properties, which have not been substantiated clinically.
DDMAC said King agreed to pull the VNRs in August following a teleconference with regulators.
The analgesic, approved in August for the management of moderate to severe pain, contains morphine sulfate and carries a long boxed warning against potentially fatal consequences of abuse, use with alcohol and improper administration.
The agency demanded that the company furnish a list of promotional materials it has pulled, and that it disseminate corrective messaging to counteract the violative releases.