FDA issues "approvable" letter for bazedoxifene

The Food and Drug Administration has issued an approvable letter for US drug major Wyeth's bazedoxifene, a selective estrogen receptor modulator for the prevention of postmenopausal osteoporosis. The letter indicates, among other things, that before the New Drug Application can be approved, the FDA must receive and analyze, as part of its benefit-risk assessment, final safety and efficacy data from a recently-completed Phase III treatment evaluation of bazedoxifene.

In addition, the agency says it must complete an acceptable establishment evaluation for the manufacturing and testing facilities for bazedoxifene. The FDA concluded its general re-inspection of Wyeth's Guayama facility in early April, and the firm has provided a written response to the agency's observations. "We believe the situation at the Guayama facility will be resolved without affecting the timing of new product launches," noted a Wyeth press release.