WYETH RECEIVES APPROVABLE LETTER FOR DEPRESSION DRUG

Wyeth Pharmaceuticals announced it has received an approvable letter from the FDA for Pristiq (desvenlafaxine succinate), a serotonin-norepinephrine reuptake inhibitor, as a treatment for adults with major depressive disorder.

"The approvable letter is in line with Wyeth's expectations, and we remain on track with our plans for Pristiq," Joseph Mahady, president of Wyeth Pharmaceuticals, said.

The FDA did not ask for any additional clinical studies prior to approval. According to the letter, FDA approval of Pristiq is subject to several conditions, including: a satisfactory FDA inspection of the company's Guayama, Puerto Rico, facility, where Pristiq will be manufactured; several postmarketing commitments, including submission of long-term, low-dose and pediatric studies; and additional clarification on the company's product education plan for physicians and patients.

The company is also seeking approval of Pristiq to treat vasomotor symptoms (VMS) associated with menopause in a separate new drug application. If approved, Pristiq will be the first and only non-hormonal drug for the treatment of VMS associated with menopause.