July 24, 2007
The FDA sent an approvable letter to Wyeth seeking more information on the company's menopause treatment Pristiq. In its letter, the FDA said that before Wyeth's Pristiq application could be approved, it would be necessary for the drugmaker to provide additional data regarding the potential for serious adverse cardiovascular and hepatic effects associated with the use of Pristiq as a treatment for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. The FDA requested that these data come from a randomized, placebo-controlled clinical trial of a duration of one year or more conducted in postmenopausal women. The agency also requested that Wyeth address certain chemistry, manufacturing and controls deficiencies prior to approval. Wyeth EVP and Chief Medical Officer Gary Stiles said in a statement that the drugmaker will work with the FDA satisfy its requests for additional data and move the medicine forward in the FDA review process.