FDA names Woodcock director of CDER
WASHINGTON Food and Drug Administration commissioner Andrew von Eschenbach has named Janet Woodcock as director of the agency’s Center for Drug Evaluation and Research.
In October 2007, while serving as the agency’s deputy commissioner and chief medical officer, where she oversaw scientific and regulatory operations, Woodcock agreed to assume the role of acting director of CDER.
Throughout her career at the FDA, Woodcock has played an integral role in advancing the health of the American public. Under her guidance, the FDA launched the Critical Path Initiative designed to close the gap between basic scientific research and the medical product development process. This initiative called for a collaborative effort to modernize the drug development process and has resulted in several prominent partnerships looking at a wide variety of scientific issues.
“Dr. Woodcock’s exemplary service since October was confirmation of her being ideally suited to lead the center during this crucial period following the passage of the Food and Drug Administration Amendments Act of 2007,” noted von Eschenbach. “The agency is fully committed to implementing the drug safety programs laid out by this act and meeting the goals set under the prescription drug user fee program, which will help ensure that CDER has the additional resources that are needed to conduct these very complex and comprehensive reviews.”
Pfizer wins Celebrex patent challenge
NEW YORK Pfizer announced that the Court of Appeals for the Federal Circuit has upheld two main patents for the company’s anti-inflammatory drug Celebrex, according to published reports.
Teva had challenged the patents, but the court ruled that the patents are valid and enforceable, but they did rule that a third patent, covering the treatment of inflammation was invalid.
Nevertheless, the decision blocks Teva from launching a generic version until May 2014.
The drug had global sales of $1.7 billion in 2007. Bear Stearns analyst project that it will reach global sales of $2.5 billion in 2008, an increase of 9 percent, and that the drug will pull in $3.1 billion by 2012.
FDA to enhance warnings on Tussionex
WASHINGTON UCB, the maker of Tussionex cough medicine, has reached out to the Food and Drug Administration to place a stronger warning on the drug. This new push stems from the report of five deaths of young children from taking Tussionex.
According to published reports, the deaths were all children under age 6, but the Belgian pharmaceutical company said that the drug is only to be taken for children and adults ages 6 and up.
Tussionex Pennketic Extended- Release Suspension contains the pain reliever hydrocodone. According to reports, the FDA is planning to issue an alert about the effects of Tussionex.