One of the largest pharmaceutical companies in the world Wyeth Pharmaceuticals has received the FDA’s third approvable letter for its innovation – bazedoxifene.
Bazedoxifene is a selective estrogen receptor modulator (SERM) developed for the prevention and treatment of postmenopausal osteoporosis. It is currently in the last phase of review by the United States' Food and Drug Administration that points at some issues that must be resolved before the FDA will grant final approval to a new drug candidate.
When approved, bazedoxifene is to be sold by Wyeth under the tradename Viviant.
Wyeth received the first approvable letter for Bazedoxifene in late April 2007. The FDA called for final safety and efficacy data from Phase III studies, and acceptable valuation of manufacturing and testing facilities where problems were found earlier in the year. The second letter was received in December.
The FDA is still concerned about potential risks of stroke and blood clots, thus requesting additional trials and data collection.