Pharmalot…Pharmalittle…
Make a commentBy Ed Silverman // June 20th, 2007 // 5:52 pm
Pfizer says the FDA issued only an approvable letter for maraviroc, a new type of HIV treatment. The drugmaker, which is investigating unapproved marketing allegations by a sales rep, is still talking to the agency about product labeling as soon as possible and in the process of submitting marketing applications worldwide to make maraviroc available globally. The FDA didn’t ask for any further studies, Pfizer spokesman Ray Kerins told Bloomberg News, but he declined to specify what label issues were under discussion.
And Merck says the FDA accepted its supplemental application for additional uses for Gardasil, which the drugmaker would like to market for protection against vaginal and vulvar cancer caused by certain human papillomavirus (HPV) strains. The application also includes data on immune memory - the ability of the immune system to continue fighting off HPV long after the vaccination. The drugmaker hopes to get a response in early 2008. The vaccine is already approved as a cervical cancer vaccine in girls and women age 9 to 26.