The FDA spelled out several conditions for the drugmaker’s SNRI antidepressant:

A clean bill of health for its troublesome Puerto Rico manufacturing plant; several post-marketing requirements, including long-term relapse prevention, low dose and pediatric studies; more info about product education; and further talks about the product name.

Wall Street expected the agency would throw up some hurdles. A key issue now, of course, is whether Wyeth can finally fix its long-standing manufacturing problems, which have plagued the company for years in various ways (a consent decree, for instance).

Wyeth needs this drug. Its Effexor antidepressant racked up nearly $3.5 billion in sales in 2005, making it th leading depression medication worldwide. That amount to nearly twenty percent of Wyeth’s total revenue. But the Effexor patent expires in 2010.

As for the product name, maybe the FDA is concerned an overzealous advertising agency will try to convince the public that Pristiq will make them feel pristine.

[tags]Antidepressants, Pristiq, Wyeth[/tags]