MADISON, N.J., Aug. 29 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE - News) announced today it has been notified by the U.S. 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.
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.
Wyeth Is Committed to Neuroscience Research and Development
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.
About Wyeth
Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third- party payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption “Item 1A, Risk Factors.” We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Source: Wyeth
