FDAnews Drug Daily Bulletin

Pristiq Mystique: Will FDA Approve Wyeth Drug? (Pharmalot)
In his blog, Ed Silverman writes about whether the FDA will approve Wyeth’s depression drug Pristiq this week.

“Wyeth, you may recall, has submitted Pristiq for two indications — treating menopausal hot flashes and major depressive disorder. The drug is, essentially, a version of Effexor XR, and Wyeth is hoping Pristiq can make its way to medicine cabinets because the Effexor patent expires in a couple of years, although one generic drugmaker is already seeking to sell a tablet form,” Silverman writes.

The FDA has set aside the application several times and issued an approvable letter for the menopausal symptoms, causing Wyeth Chairman Bob Essner to chastise “the FDA for its newly found conservative stance and for ‘creating monopolies.’ The setbacks are being cited for a 10 percent cut in the drugmaker’s global workforce,” Silverman adds.