Merck's Plendil approved
Executive Summary
Merck's extended-release formulation of felodipine approved by FDA July 25. Plendil, Merck's first calcium channel blocker, is indicated for "treatment of hypertension," and "may be used alone or concommitantly with other antihypertensive agents," labeling states. The Swedish firm AB Hassle initially developed Plendil; Merck has exclusive U.S. marketing rights under a 1982 joint venture deal with Hassle's parent firm, AB Astra. Plendil will be available in 5 mg and 10 mg tablets. Marketing details are not yet available. Merck's NDA for Plendil was submitted on Feb. 26, 1988.