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

Testosterone Gel Makers Brace For REMS, Black Box Warning

This article was originally published in The Pink Sheet Daily

Executive Summary

Risks of skin contact with children and women were known, but severity of adverse events took the field by surprise.

You may also be interested in...



Endo's Fortesta To Join Crowded Testosterone Treatment Market In Q1

FDA approved the testosterone gel despite concerns about secondary exposure, but Fortesta will be competing against entrenched rivals and a new treatment from Eli Lilly.

Endo's Fortesta To Join Crowded Testosterone Treatment Market In Q1

FDA approved the testosterone gel despite concerns about secondary exposure, but Fortesta will be competing against entrenched rivals and a new treatment from Eli Lilly.

Lilly/Acrux's Axiron Delivers Testosterone Differently, But The Label Remains The Same

Newly-approved testosterone therapy product is delivered via the armpit, but FDA says the same precautions are necessary as for other products applied to the shoulders and upper arms.

Related Content

Topics

UsernamePublicRestriction

Register

PS069518

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