Wyeth gets tentative US approval for Pristiq

US drug major Wyeth has received an approvable letter from the Food and Drug Administration for Pristiq (desvenlafaxine succinate), a serotonin-norepinephrine reuptake inhibitor, studied as a treatment for adults with major depressive disorder.

According to Joseph Mahady, president of Wyeth Pharmaceuticals, the letter is in line with the company's expectations. "We remain on track with our plans," he said, adding that "we are working toward resolution of all outstanding issues at our manufacturing site in Guayama, Puerto Rico, and have already made significant progress in meeting previously established commitments."

According to the approvable letter, FDA clearance for Pristiq is subject to several conditions, including a satisfactory agency inspection of Wyeth's Guayama, facility, which is where Pristiq will be manufactured; several post-marketing commitments, including submission of long-term relapse prevention, low-dose and pediatric studies; additional clarity around the company's product education plan for physicians and patients; and confirmation by the FDA of the acceptability of the proprietary name, Pristiq.