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.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: