Wyeth’s Hot Flash: Pristiq “Approvable” Delays Vasomotor Claim At Least A Year
Executive Summary
Building a stable of next-generation women's health products is not coming easily to Wyeth. The drug maker received an "approvable" letter July 23 for its Effexor XR follow-on Pristiq for treatment of vasomotor symptoms of menopause, including night sweats and hot flashes
You may also be interested in...
First Non-Hormonal Hot Flash Drugs Could Clear FDA Panel In March
Depomed’s gabapentin and Noven Pharmaceuticals’ paroxetine to get advisory committee review for a menopausal hot flash indication; while Phase III data for both drugs are positive, certain endpoints did not reach statistical significance in at least one study.
Wyeth Finally Cleared For Pristiq Lift-Off, But With Lower Dose
Approval of Wyeth's Pristiq (desvenlafaxine) comes at the lower dose that was submitted late in the review process and with a request for a postmarketing study to determine if even lower doses would be effective
Wyeth Looks To Specialty Markets As Generics Challenge Current Model
Wyeth's R&D pipeline is evolving the firm toward more specialized areas as several of its blockbuster products face patent expirations and generic challenges