FDA issues Wyeth approvable letter for bazedoxifene

COLLEGEVILLE, Pa. Wyeth Pharmaceuticals announced that they have received a second approvable letter for Bazedoxifene from the Food and Drug Administration.

This follows a first letter from April in which the FDA stated that bazedoxifene, indicated for the prevention of postmenopausal osteoporosis, will not be approved until the administration analyzed safety and efficiency data from the recently completed Phase 3 treatment study on the drug, according to the letter. Also, the FDA had to complete an acceptable establishment evaluation for the manufacturing and testing facilities.

The FDA this week stated that the Wyeth Asian studies that were submitted on Nov. 9 and Dec. 14, 2007, were not reviewed for this action. Wyeth believes the data from these nearly 1,000 women provide additional support for a favorable benefit to risk ratio for bazedoxifene in the prevention of postmenopausal osteoporosis.

“We look forward to working with the FDA to resolve these issues. Wyeth is dedicated to identifying therapies for the millions of postmenopausal women who are at risk for increased bone loss,” said Gary Stiles, executive vice president and chief medical officer at Wyeth Pharmaceuticals.