Press Release: Pfizer Receives Approvable Letter From FDA For Maraviroc
Pfizer Receives Approvable Letter From FDA For Maraviroc NEW YORK -- Pfizer announced today the U.S. Food and Drug Administration (FDA) issued an approvable letter for maraviroc, which is under review as a therapy for treatment-experienced patients infected with CCR5-tropic HIV-1. We continue our discussions with the FDA to address outstanding questions and finalize the product labeling as soon as possible. Pfizer is committed to making maraviroc available to the thousands of patients with HIV whose virus has become resistant to one or more currently available treatment options. To date, more than 2,000 patients worldwide have received or are currently receiving treatment with maraviroc through clinical trials. Pfizer has also established an expanded access program (EAP) in 30 countries. The EAP is a clinical study that provides maraviroc in countries to patients who have limited treatment options prior to approval. Pfizer is currently in the process of submitting marketing applications around the world to make maraviroc available globally. DISCLOSURE NOTICE: The information contained in this release is as of June 20, 2007. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information that involves substantial risks and uncertainties regarding a product candidate that is under review by the United States Food and Drug Administration (FDA) and regulatory authorities in various other countries. Such risks and uncertainties include, among other things, whether and when the FDA and other regulatory authorities will approve the product candidate, their decisions regarding labeling and other matters that could affect its availability or commercial potential, as well as competitive developments. A further list and description of risks and uncertainties can be found in Pfizerâ€™s Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and in its reports on Form 10-Q and Form 8-K.