Medtech Insight 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

Amersham Myoview diagnostic agent cited for off-label promotions in Aug. 21 FDA warning letter.

This article was originally published in The Gray Sheet

Executive Summary

AMERSHAM MYOVIEW PROMOTIONS FOR UNAPPROVED INDICATIONS are cited in a warning letter issued by FDA's Division of Drug Marketing, Advertising, & Communications Aug. 21. FDA maintains that Amersham is promoting the radiopharmaceutical diagnostic agent for the unapproved uses of pharmacologic stress testing and assessment of heart function when the technetium Tc99m tetrofosmin product is only approved for myocardial imaging under exercise and resting conditions.

You may also be interested in...



Nycomed Amersham's Myoview Approvable For Rx Stress Testing Indication

Nycomed Amersham Imaging says it has received word from FDA that its Myoview kit for the preparation of technetium Tc-99m tetrofosmin is approvable for use with pharmacologic stress agents.

Pandemic Response In US Consumer Health Market: OTC Pain Relief And Cough/Cold Purchases

Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.

UsernamePublicRestriction

Register

MT008670

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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