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ABBOTT'S HYTRIN (TERAZOSIN) IS "APPROVABLE" AS ONCE-A-DAY ANTIHYPERTENSIVE

Executive Summary

ABBOTT'S HYTRIN (TERAZOSIN) IS "APPROVABLE" AS ONCE-A-DAY ANTIHYPERTENSIVE more than three years after the NDA was filed in September 1983. Abbott previously had the trademark Vasocard for the product but changed the drug's name to Hytrin -- the brandname used in other countries. In recent preapproval ads, Abbott has alerted MDs that Hytrin is "coming soon." For example, advertisements appear in the Dec. 5 issue of The Journal of American Medical Association and in the Nov. 20 issue of The New England Journal of Medicine. At its March 27 meeting, FDA's Cardio-Renal Drugs Advisory Committee agreed that terazosin should be approved -- pending review of data for tumorigenicity. The committee requested reanalysis of data for the use of the drug with diuretics as well as postmarketing studies on its use as monotherapy and combination therapy ("The Pink Sheet" March 31, p. 6). The approvable designation for Hytrin comes soon after FDA gave final market clearance for another new chemical entity antihypertensive. Robins' Tenex was approved on Oct. 27 and classified as a 1C product, a new molecular entity with little or no therapeutic gain.
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