Healthy Skepticism Library item: 13339
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
King Gets Warning Letter Over Avinza Promotion
PharmaLive 2008 Mar 27
http://pharmalive.com/news/index.cfm?articleID=526338&categoryid=9&newsletter=1
Notes:
Link to FDA warning letter:
http://www.fda.gov/CDER/warn/2008/Avinza-wl.pdf
Link to promotional material:
http://www.fda.gov/CDER/warn/2008/Avinza-Promo.pdf
Full text:
The FDA yesterday posted on its website a warning letter sent to King Pharmaceuticals about promotional material for pain drug Avinza. The agency said it reviewed a 22-page File Card for the drug and found it “false or misleading in that it presents efficacy claims for Avinza but fails to communicate and minimizes risks associated with its use, fails to present the limitations to its approved indication, and presents unsubstantiated efficacy claims.”
