Wyeth officials have vowed to work with the FDA to speed the approval of Pristiq, a drug that can be used to treat depression and menopausal symptoms.
Wyeth officials have vowed to work with the FDA to speed the approval of Pristiq (desvenlafaxine), a drug that can be used to treat both depression and menopausal symptoms. Though the FDA has given Wyeth an approvable letter for Pristiq, it wants the company to conduct an entire new study of the drug to collect more information on its effects on the heart and liver. A small number of menopausal women using the drug in a study suffered serious heart or liver complications, prompting the agency to demand a new randomized, placebo-controlled clinical trial of at least one year from Wyeth. The trial, however, is not expected to delay the approval of Pristiq as a depression treatment, which is slated for the first quarter of next year.
To see more Hot off the Press news articles, click here.
To go to the Drug Topics homepage, click here.