Merck's Plendil approved
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.
You may also be interested in...
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 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
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