Pink Sheet 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

Testosterone Products Need Post-Market Cardiovascular Trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Labeling updates will also clarify approved uses and warn of possible increased risk of heart attack and stroke; impact on products in development unclear.

You may also be interested in...



Another Testosterone Warning – This Time For Abuse

Action follows agency review of 81 adverse events reported with testosterone/anabolic androgenic steroid misuse, abuse, or dependence over 45 years; discussions continue on cardiovascular study.

Product Liability Suits: Testosterone, Lipitor Grow While Yaz, Pradaxa Settle

2014 saw some big settlements in personal injury suits involving Rx drugs, but it’s unclear whether this is a trend or just situation-specific decision-making, since fierce litigation continues for many other products.

Disease-Awareness Ads Thrive In Regulatory No-Man’s Land

FDA says its hands are tied when it comes to curbing practices such as the testosterone ads its advisory committees have found problematic, but are the agency’s powers really that limited?

Related Content

Topics

Related Companies

Related Deals

Latest News
See All
UsernamePublicRestriction

Register

PS005910

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

Cancel