Allergan Tazoral "not approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Allergan will continue seeking a psoriasis indication for its oral tazarotene product Tazoral, the firm says following FDA's Sept. 24 "not approvable" letter. Among the "non-approvability issues" are the needs for a non-inferiority trial in severe psoriasis, an "acceptable" risk management plan and manufacturing deficiencies. Allergan "will work with the FDA to clarify" the request for a non-inferiority trial. The firm says it is "in the process of developing an appropriate risk mangement plan." The manufacturing issue "is either resolved or will be resolved shortly to the FDA's satisfaction," Allergan says. FDA's Dermatologic & Ophthalmic Drugs/Drug Safety & Risk Management advisory committees said that the Tazoral risk management plan was inadequate during a July 12 joint meeting...