Unapproved hydrocodone crackdown

Executive Summary

FDA is allowing manufacturers of unapproved cough-suppressants containing hydrocodone 30 days to cease production of such products labeled for use in children under six years of age before agency begins enforcement actions. Agency officials estimate there are currently 200 unapproved antitussants containing hydrocodone on the market, compared to seven approved products, suggesting that majority of patients are prescribed unapproved drugs. Reported medication errors based on labeling confusion and formulation differences, neither of which FDA can control for unapproved products, warrant priority enforcement, according to CDER Office of Compliance Director Deborah Autor. FDA is taking stronger enforcement measures against unapproved products following a 2006 compliance policy guide (1"The Pink Sheet" June 12, 2006, p. 10)...