WYETH DEPRESSION DRUG GETS CONDITIONAL APPROVAL

The FDA has issued an approvable letter for Wyeth's major depressive disorder drug Pristiq.

Before the FDA approves Pristiq, the agency must inspect the company's facility in Guayama, Puerto Rico, where the drug will be manufactured, the Jan. 22 letter said. The drug's approval also depends on the submission of long-term relapse prevention, low dose and pediatric studies, as well as more information on the company's physician and patient education plan and agency confirmation of the drug's name.

Wyeth President Joseph Mahady said Jan. 23 the company was already resolving issues at the Puerto Rico facility.

The company has also submitted another new drug application (NDA) for Pristiq, a serotonin-norepinephrine reuptake inhibitor, to treat vasomotor symptoms associated with menopause. Wyeth said it expects a response from the FDA in the second quarter of 2007. If the FDA approves the NDA, Pristiq will be the only nonhormonal medication for the treatment of vasomotor symptoms associated with menopause, Wyeth said.

Pristiq is the successor to Wyeth's depression drug Effexor, which will lose patent protection in 2010. Effexor is the most widely used antidepressant globally, according to Wyeth.