Wyeth received an approvable letter from the FDA for Pristiq, a serotonin-norepinephrine reuptake inhibitor (SNRI), currently under review for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. However, the company needs to provide additional data regarding the potential adverse cardiovascular and hepatic effects associated with the use of Pristiq in this indication. The Agency requested a one-year clinical trial conducted in postmenopausal women. The...