ICI's TENORMM I.V. WILL BE LAUNCHED NOV. 1; APPROVED FOR HEART ATTACK

Executive Summary

ICI's Tenormin (atenolol) I.V. will be made available to the trade Nov. 1. FDA approved the injectable beta blocker on Sept. 13 for the treatment of myocardial infarction. A supplemental NDA for the oral drug was also approved, allowing use in myocardial infarction after initial I.V. therapy. The myocardial infarction indication is based primarily on results of the International Study in Infarct Survival (ISIS-1) trial, which evaluated atenolol I.V. plus conventional therapy against conventional therapy alone in 16,000 patients. The trial found that atenolol reduced mortality 15% over conventional therapy alone at one week. Mortality was reduced by 30% in the first 24 hour period after the heart attack.