Post Marketing Commitments

As part of the U.S. regulatory approval process for new medicines and new uses for existing medicines, companies may be required to conduct additional studies and testing to support the safety and effectiveness of their medicines. These studies are referred to as post marketing commitments (PMCs). This Web site provides some general information about how post marketing commitment studies are conducted, as well as status information on listed U.S. post marketing commitment studies. FDA information about post marketing commitments can be found at the FDA Web site.

About the Information Posted on This Web Site:

This Web site contains information about Pfizer’s U.S. pharmaceutical post marketing commitments. The post marketing commitments listed here include pre-clinical, clinical and epidemiological studies or testing agreed to by Pfizer (including its subsidiaries) and the FDA, and are used to gather additional information about the safety, efficacy, or use of approved Pfizer medicines. This Web site provides the current status of Pfizer post marketing commitments listed on the FDA Web site and includes post marketing commitments established for Pfizer medicines in the U.S. since August 1, 2000. New post marketing commitments will be listed on this Web site as they are established. Released or completed post marketing commitments will be removed from the site.

This Web site does not contain technical chemistry, manufacturing and control (CMC) commitments, or commitments for medicines where Pfizer is not the FDA license holder. Information about Pfizer’s post marketing commitments to the U.S. FDA is believed to be correct at the time that the information is posted, and is subject to change as progress is made in fulfilling the commitments.

This Web site is updated monthly. The status of post marketing commitments shown on the FDA Web site may differ from information displayed on this site, due to differences in the timing of updates made to the FDA Web site. The number of commitments on the two sites may also differ, due to the frequency of such updates and/or due to multiple reporting of single commitments on the FDA Web site.