The USFDA has recently granted an approvable letter to Wyeth Pharmaceuticals’ Pristiq™ (desvenlafaxine succinate), a serotonin-norepinephrine reuptake inhibitor (SNRI) under investigation as a treatment for adult patients with major depressive disorder (MDD).
FDA’s approvable letter subjected Pristiq’s approval on several conditions, including the following:
- A satisfactory FDA inspection of the Company's Guayama, Puerto Rico facility, which is where Pristiq will be manufactured
- Several post-marketing commitments, including submission of long-term relapse prevention, low dose and pediatric studies
- Additional clarity around the Company's product education plan for physicians and patients
- Confirmation by the FDA of the acceptability of the proprietary name, Pristiq
Pristiq is an SNRI under investigation as potential treatment for adult MDD patients.
Aside from the NDA for NDD, Wyeth also filed a NDA for VMS associated with menopause and expects an FDA action letter in the second quarter of 2007. If approved, Pristiq will become the first and only non-hormonal medicine for the treatment of vasomotor symptoms (VMS) associated with menopause.
Wyeth Pharmaceuticals (10944776) is a division of Wyeth (NYSE: WYE).
Find more details from the press release.
.jpg)
Comment Preview