CIBA-GEIGY's SECOND BETA-BLOCKER IS TRASICOR (OXPRENOLOL)
CIBA-GEIGY's SECOND BETA-BLOCKER IS TRASICOR (OXPRENOLOL), which received FDA approval for the treatment of hypertension on Dec. 29. The product, developed by Ciba, joins Geigy's Lopressor (metoprolol) which has been marketed in the U.S. since 1978. Trasicor is Ciba-Geigy's first new chemical entity approval since the agency cleared the antidepressant Ludiomil in late 1980. Schering A.G.'s Berlex subsidiary has co-marketing rights to the drug in the U.S. under a licensing agreement. Berlex has given the drug the tradename ISET. Neither firm has announced marketing plans for the drug. FDA classified oxprenolol under its internal classification system as 1C, a new chemical entity that the agency believes represents "little or no therapeutic gain." The drug was reviewed by the agency's Cardio-Renal Advisory Cmte. in February 1980. At that time the cmte. recommended that prior to approval the target population be better defined in view of clinical trial results that found the drug less effective than propranolol. Oxprenolol was approved in three dosages, 20 mg, 40 mg, and 100 mg caps. The labeling calls for t.i.d. administration.
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