In the letter, the FDA identified several remaining questions regarding issues that had been previously identified during the review process and that were not fully resolved by the company’s complete response to the first approvable letter. The FDA has requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events. The agency also identified certain issues concerning data collection and reporting and requested additional source documents.
The agency 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.
Gary Stiles, executive vice president, chief medical officer, Wyeth Pharmaceuticals, said: “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.”