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

Copaxone Promos Can’t List Risks Product Doesn’t Have, Especially Incorrectly, FDA Warns

This article was originally published in The Pink Sheet Daily

Executive Summary

The first warning letter of the year from FDA’s Office of Prescription Drug Promotion goes to Teva for web pages and materials displayed at a medical conference that overstated the safety and efficacy of its MS drug Copaxone.

You may also be interested in...



FDA Declares Pox On Both Houses In Enforcement Letters For Curosurf, Infasurf

In separate “notice of violation” letters issued Oct. 31 but posted several days apart, FDA rejected superiority claims on the part of Cornerstone Therapeutics and Ony for their respiratory distress syndrome drugs.

Equetro Web Pages Omit Risk Info, Make Unsupported Claims On Depression, FDA Says

The agency sent Validus Pharmaceuticals a letter objecting to web pages that minimize the risk of suicidality with use of the bipolar disorder drug and suggest it does not worsen depression or induce weight gain.

MS Product Ads Kept On Short (Study) Leash As Avonex Draws FDA Letter

FDA says a chart on Biogen Indec’s website implies Avonex is superior to Copaxone, Rebif, Betaseron and Extavia; the notice of violation was issued the same day FDA sent a warning letter to Teva citing its Copaxone promos.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS073896

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