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


Testosterone Products Need Post-Market Cardiovascular Trial

This article was originally published in The Pink Sheet Daily

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...

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?

The Next Estrogen Or An Off-Label Star: Can FDA Turn Back The Clock On Testosterone?

Testosterone replacement products took a hit after an FDA advisory committee, but even if the agency follows their advice, panelists worried a label change will not curb use in the now infamous “Low-T” population; meanwhile, a vigorous pipeline of new testosterone formulations may be left in limbo.


Related Companies

Related Deals




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