Wyeth has been notified by the US Food and Drug Administration (FDA) that the agency has extended by three months the action date for its review of the New Drug Application (NDA) for desvenlafaxine succinate extended release for the treatment of major depressive disorder. The FDA's revised action date for the NDA for desvenlafaxine succinate will now be January 22, 2007.

The FDA has the option of extending the typical 10-month review period if a sponsor submits a major amendment, as defined by the FDA, during the last three months of the review. In this instance, Wyeth had submitted its analyses of pre-clinical carcinogenicity data in study reports as part of the original NDA in December 2005, and subsequently submitted the raw data sets from these studies, a Wyeth release stated.

Wyeth had to resubmit that same raw data in the required format on July 31, 2006, which fell during the last three months of the FDA's review period. The decision to extend the review period was based solely on the submission of re-formatted data sets. The Agency has not communicated any new concerns regarding the NDA submission. This extension is not likely to have any bearing on the current launch plans.

As a leader in neuroscience, Wyeth's discovery and development of desvenlafaxine succinate demonstrates its commitment to developing pharmaceutical products to help address the unmet needs of patients living with mental illness. In addition to the investigational compound desvenlafaxine succinate for major depressive disorder, the Company also has active research programs in mental health areas, including schizophrenia, bipolar disorder and Alzheimer's disease.