Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

UsernamePublicRestriction

Register

PS051363

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel