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

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

Executive Summary

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.

You may also be interested in...



Surprise Approval For Clarus' Oral Testosterone Includes Black Box, No REMS

Jatenzo clears US FDA 15 months after second negative advisory committee review. 

US FDA Approval Climate: What Do The Oral Testosterone Reviews Tell Us?

Second go-round for oral testosterone could have marked new boundary on how far FDA is willing to go in approving new entrants to a market with widespread historic off-label use and CV risks.

Testosterone Label Changes Could Make Advertising More Challenging

FDA proposal obtained by “The Pink Sheet” DAILY eliminates language describing symptoms of low testosterone.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS056382

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