Monday, June 13, 1994
ROCKVILLE, Md. - An FDA advisory committee on Friday approved an accelerated dose regimen of Genentech Inc.'s Activase tPA for treatment of acute myocardial infarction, provided the FDA with general guidance on label inserts for the new dosage, and discussed design issues for future cardiovascular trials.
The Cardiovascular and Renal Drugs Advisory Committee recommended approval of administration of Activase over a 90-minute period, rather than the currently approved three-hour period. The recommendation was based on data from the GUSTO trial. The committee did not place any limitations on indications for the new dosage.