Wyeth announced late Friday that it won FDA approval for Pristiq, its next-generation version of the antidepressant Effexor. Wyeth was looking for an approval of Pristiq to offset the considerable lossesÂ that are likely to follow Effexor's loss of patent protection in 2010. Pristiq is a norepinephrine reuptake inhibitor, as is Effexor. But researchers say the drug can be used in therapeutic doses from the day it is prescribed, as opposed to the steadily ascending doses that doctors currently prescribe Effexor.
The approval came with strings. Wyeth has to conduct a string of trials covering long-term maintenance, sexual dysfunction, pediatric studies and lower-dose studies.
Wyeth presents Pristiq data. Report
Wyeth's Pristiq shows benefits in clinical trial. Report
FDA issues approvable letter for Pristiq. Report
Wyeth expects provisional OK for Pristiq. Report