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.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth