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

MALLINCKRODT's HEXABRIX IS A 1C APPROVAL

Executive Summary

MALLINCKRODT's HEXABRIX IS A 1C APPROVAL indicated for cerebral angiography, peripheral arteriography, selective visceral arteriography and selective coronary arteriography with or without left ventriculography, according to the FDA-approved labeling for the injectable x-ray contrast medium. Hexabrix was approved by the agency July 26 after a 46 month review. The lC rating signifies a new molecular entity representing little or no therapeutic gain. Mallinckrodt noted that approximately 12 mil. procedures requiring the use of contrast media are performed annually. The firm said that the product would be available in early September. In a press release announcing approval of the diagnostic, Mallinckrodt said, "Hexabrix represents a new generation of new low-osmolality iodinated contrast media which are better tolerated by patients than the older products available to the medical community." The firm explained that "some of the side effects associated with the injectable iodinated x-ray contrast media are related to the relatively high osmolality ]number of particles relative to volume of the solution[ of the solution."

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

LL1131980

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