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 losses [1]Â 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.
- here's the release [2]Â on the approval
- read the report [3] from TheStreet
Related Articles:
Wyeth presents Pristiq data. Report [4]
Wyeth's Pristiq shows benefits in clinical trial. Report [5]
FDA issues approvable letter for Pristiq. Report [6]
Wyeth expects provisional OK for Pristiq. Report [7]
Links:
[1] http://www.fiercepharma.com/story/sun-copycat-cut-500m-wyeth-sales/2007-12-20
[2] http://www.fiercebiotech.com/press-releases/fda-approves-wyeth-pharmaceuticalss-pristiq-treatment-adult-patients-major-depressive
[3] http://www.thestreet.com/s/wyeths-pristiq-wins-fda-approval/newsanalysis/drugs/10405757.html?puc=googlen&cm_ven=GOOGLEN&cm_cat=FREE&cm_ite=NA
[4] http://www.fiercebiotech.com/story/wyeth-presents-pristiq-data/2007-12-12
[5] http://www.fiercebiotech.com/story/wyeths-pristiq-shows-benefits-clinical-trial/2007-10-15
[6] http://www.fiercebiotech.com/story/fda-approves-pristiq-for-depression/2007-01-24
[7] http://www.fiercebiotech.com/story/wyeth-expects-provisional-ok-for-pristiq/2007-01-22