Pfizer Estrostep

Executive Summary

Journal ad claim that oral contraceptive shows "no significant weight gain" is not supported by adequate and well-controlled clinical trials, Division of Drug Marketing, Advertising & Communications states in April 16 letter. Two multi-center six-month studies cited to support claim are inadequate because weight gain or loss was not a prospectively defined endpoint, ad division says. The ad, which appeared in March and April issues of nine professional journals, has been pulled, Pfizer said. Pfizer's Estrostep NDA for treatment of moderate acne has been pending at FDA since April 2000