King warned on Embeda VNRs

Share this article:

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.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Pharmaceutical

 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.