In Vivo is part of the Business Intelligence Division 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

Molecular Biosystems' Albunex

Executive Summary

Contrast imaging agent for use with ultrasound is "approvable" at FDA, company announces April 28. The agency's letter asks the firm to make some labeling changes and conduct post-approval studies "relating to the nature and frequency of any reported 'adverse device effects' (ADEs)" as requested by FDA's Radiological Devices Panel in July 1992. MBI says the ADEs that occurred during clinical trials "were both minor and resolved without treatment," and the San Diego-based company will respond to FDA "in the next few days." Albunex will be marketed in the U.S. by Mallinckrodt Medical
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS024411

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