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


Endo’s Testosterone REMS, Revised Dosing Don’t Solve FDA Concerns

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA briefing documents for the advisory committee review of Endo’s Aveed cite the “excessive burden” imposed by any one of the REMS restrictive elements, given the injectable testosterone’s limited additional benefit compared to other available treatment options.

You may also be interested in...

REMS Can’t Help Endo’s Aveed – Won’t Address Unpredictable Safety Events, FDA Advisors Say

Without predictive factors to determine who is likely to get a severe post-injection reaction, FDA advisory committees say Endo’s proposed REMS for its long-acting testosterone is unlikely to allay safety concerns.

Endo Aveed’s Safety Problems Weigh On Cmte., But Hope For Narrower Population Tips Scale For Some

FDA’s Reproductive Health Drugs and Risk Management advisory committees split on whether the safety of Endo’s injectable testosterone Aveed is safe for the proposed indication, with many on both sides seeing value in the drug for patients who “have to take testosterone.”

Third Time’s A Charm? Endo’s Injectable Testosterone Finally Ready For Advisory Cmte.

FDA says reports of oil embolism and anaphylactic reations with other testosterone injectables also will be part of the discussion during an April 18 meeting of the Reproductive Health Drugs and Drug Safety and Risk Management advisory committees to review Aveed (testosterone undecanoate).

Related Content


Related Companies




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