In Brief: Roche's Vesanoid
Executive Summary
Roche's Vesanoid : All-trans retinoic acid product is "approvable" as of July 28. In December, FDA's Oncologic Drugs Advisory Committee recommended that Vesanoid be approved for the second-line treatment of acute promyelocytic leukemia in refractory or anthracycline-contraindicated patients ("The Pink Sheet" Dec. 19, 1994, p. 6). Outstanding issues for approval include labeling discussions and manufacturing consistency issues...