SYNTEX RECEIVES "APPROVABLE" LETTER FOR TICLID (TICLOPIDINE)

Executive Summary

SYNTEX RECEIVES "APPROVABLE" LETTER FOR TICLID (TICLOPIDINE) on Sept. 18. Syntex filed the NDA (19-979) for the platelet aggregation inhibitor on June 26, 1989. Ticlid was designated a "subpart E" drug, giving the NDA expedited review status, following the NDA filing ("The Pink Sheet" July 31, 1989, T&G-7). Syntex observes that it is discussing "final labeling and a patient package insert with FDA." Ticlid was recommended for approval by FDA's Cardio-Renal Drugs Advisory Committee on Dec. 14, 1990 for the prevention of stroke recurrence in men and women intolerant to aspirin, with the caveat that Ticlid patients receive biweekly monitoring for neutropenia ("The Pink Sheet" Dec. 17, T&G-1). The recommended indication was considerably narrower than the one sought by the company. Syntex had wanted labeling for Ticlid that would have included indications for a broad range of stroke prevention and mortality reduction in patients with previous strokes. Despite data showing as much as a 47% reduction in the risk of fatal and nonfatal stroke compared to aspirin, the committee felt that a 1% incidence of neutropenia among Ticlid patients precluded the drug's use in the more general population.