Wyeth Effexor Promotion Cited By U.K. Health Authorities
This article was originally published in The Pink Sheet Daily
Executive Summary
Medicines & Healthcare products Regulatory Agency says venlafaxine promotion was found to "openly question" recommendations for restricted use of the antidepressant in cardiovascular patients. Wyeth says it was in the process of updating promotional material to reflect new labeling when the violation occurred.
You may also be interested in...
Prevnar, Effexor, Enbrel Powering Strong First Quarter For Wyeth
Normalization of Prevnar demand after the correction of supply problems will play a major role in delivering first quarter earnings per share levels significantly higher than analyst estimates, CFO Martin says. Third quarter results may be down compared to 2004 because of high anticipated R&D spending.
Wyeth To Challenge U.K. Effexor Restrictions
Effective Dec. 6, U.K. labeling for Effexor contraindicates the antidepressant in patients with cardiovascular disease, recommends a baseline ECG for new patients, and restricts prescribing to specialists. Wyeth intends to file a formal appeal of the decision within two weeks.
NME Slowdown Shows Market Pressure On Me-Toos, Not FDA Caution – Lutter
DURHAM, N.C. - The decline in FDA's tally of new molecular entity approvals stems from fewer approvals of non-innovative products in recent years, while approvals of truly innovative products has largely held steady, according to FDA Deputy Commissioner for Policy, Planning and Preparedness Randall Lutter