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

Wyeth Delayed Pondimin Label Revision Pending Redux Review, Plaintiffs Say

Executive Summary

Wyeth-Ayerst stalled a labeling revision for the company's diet drug Pondimin (fenfluramine) until FDA completed its NDA review of the company's related diet drug Redux NDA, plaintiffs' attorneys in the N.J. fen-phen class action suit Vadino, Varalli, and DeBerardinis v. American Home Products maintain.

You may also be interested in...



Wyeth Found No Signal Of Valvular Heart Disease In Diet Drug AEs - Deitch

Wyeth-Ayerst identified no signal of valvular heart disease prior to 1997 in adverse drug event reports submitted for the weight loss agents Pondimin (fenfluramine) and Redux (dexfenfluramine), former Wyeth-Ayerst Senior VP-Medical Affairs Marc Deitch, MD, testified in the New Jersey diet drug class action suit.

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
UsernamePublicRestriction

Register

PS034766

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