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


Levothyroxine false claims lawsuit

Executive Summary

Watson is enjoined from making claims that Abbott's Synthroid is not safe and effective due to FDA's denial of its citizen petition, under a preliminary injunction granted by Chicago federal court Judge David Coar July 19. Watson is considering appealing the order. Abbott filed suit against Watson in June over Watson's promotions for its FDA-approved levothyroxine product Unithroid. Watson's claims "that Synthroid will be taken off the market come August 2001" were not found to be misleading, given FDA's "ambiguous" pronouncements about the fate of unapproved products, the decision says. FDA clarified its regulatory plans for unapproved levothyroxine products in a July 12 guidance (1"The Pink Sheet" July 16, p. 16)

You may also be interested in...

FDA Seeks To Cut Abbott Synthroid Distribution To 60% By August 2002

An FDA guidance on levothyroxine products calls for Abbott to reduce Synthroid distribution to 60% of current levels by August 2002, about the time the company anticipates FDA approval for the drug.

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




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