In Brief: Matrix AccuSite

Executive Summary

Matrix AccuSite: Company halts further development of AccuSite (fluorouracil/epinephrine) injectable gel following the receipt of a second "not approvable" letter from FDA for NDA for genital warts. The agency letter focuses on "a bump-like thickening or swelling (induration) at the site of injection," Matrix said. "The agency feels the persistence of induration, although it typically resolved naturally, may be an indicator of localized inflammation." The company is seeking a meeting with FDA. AccuSite is approved in the U.K., Ireland, and the Netherlands...