Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Takes Action Against Propoxyphene But Keeps It On The Market

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA denies Public Citizen's request for withdrawal, instead mandating new studies to assess propoxyphene's link to overdoses and requiring a boxed warning and MedGuide.

You may also be interested in...



Propoxyphene Marketing Halted By FDAAA-Required QT Safety Study

The opioid, marketed under the Darvon and Darvocet brands and in generic form, has the ignominious distinction of being the first drug pulled from the market based on results of a post-marketing safety study required under the 2007 law.

Propoxyphene Marketing Halted By FDAAA-Required QT Safety Study

The opioid, marketed under the Darvon and Darvocet brands and in generic form, has the ignominious distinction of being the first drug pulled from the market based on results of a post-marketing safety study required under the 2007 law.

A Lack Of Data Keeps Propoxyphene On The Market ... For Now At Least

The lack of clear data substantiating the risk of fatal overdose with propoxyphene-containing drug products seems to have led FDA to its decision to keep the products on the market - and thus deny Public Citizen's petition for their withdrawal

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS069796

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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