Wyeth gets second FDA approval letter for bazedoxifene

The US Food and Drug Administration (FDA) has issued a second approvable letter for bazedoxifene, a selective estrogen receptor modulator, for the prevention of postmenopausal osteoporosis being developed by Wyeth Pharmaceuticals.

Wyeth submitted a separate New Drug Application to the FDA for bazedoxifene for the treatment of postmenopausal osteoporosis in July 2007, which was accepted for filing in September 2007, with an action date in May 2008.

The FDA identified several remaining questions regarding issues that had been previously identified during the initial review process and has requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events. The FDA also identified certain issues concerning data collection and reporting and requested additional source documents.

It did not request the initiation of any new studies and has suggested an end-of-review conference between Wyeth and the FDA to address the remaining issues.

Wyeth said it was now addressing the issues raised.