GLAXO LANOXIN LABEL REWRITE SHOULD AWAIT FURTHER CHF MORTALITY DATA; LABEL SHOULD RETAIN ATRIAL FIBRILLATION, HEART FAILURE INDICATIONS -- ADVISORY CMTE.
Executive Summary
Glaxo Wellcome's Lanoxin (digoxin) tablets should not be relabed until further mortality data for congestive heart failure are analyzed from the recently completed Digitalis Investigation Group trial, FDA's Cardiovascular & Renal Drugs Advisory Committee recommended at its May 2 meeting.