Wyeth wins OK to sell Pristiq for depression

By Ransdell Pierson

NEW YORK (Reuters) - Drugmaker Wyeth won U.S. approval to sell a drug called Pristiq to treat depression, the U.S. Food and Drug Administration said on Friday.

An FDA spokesperson confirmed the approval, but provided no other details.

Pristiq is a derivative of Wyeth's widely used Effexor depression drug and the company had hoped it would be approved long before Effexor loses its U.S. patent protection in 2010 and faces generic competition.

But some analysts have dismissed Pristiq as a "me, too" drug, with few distinguishing characteristics and modest sales potential.

Wyeth also has tested Pristiq as a treatment for hot flashes in post-menopausal women, but the FDA last summer said it could not approve the drug for that condition until Wyeth resolved concerns about potentially serious heart and liver problems. The company plans to begin a new study in coming months to verify its safety.

The drugmaker has not cited any major advantages Pristiq might have over the $3.8 billion-a-year Effexor in treating depression, but has suggested it may be less likely to interact with other medicines because it is broken down differently.

"This is a very important condition," said Wyeth Chief Executive Officer Bernard Poussot, "and physicians need all the options" in treating patients.

Despite skepticism among many industry analysts about the drug's commercial appeal, Poussot said in an interview that Wyeth remains confident Pristiq will eventually garner annual sales of $1 billion or more as a treatment for depression.