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

Richter’s Uterine Fibroid Drug Esmya Hit By Liver Safety Concerns In EU

Executive Summary

EU safety restrictions relating to liver toxicity concerns are likely to lead to changes to the labeling of Richter’s uterine fibroid product Esmya and to a sharp drop in the product’s sales. The moves could also affect the product in the US, where it was filed for approval last year.

You may also be interested in...



Liver Damage Worries Lead To Further EU Restrictions On Richter’s Esmya

The European Medicines Agency’s pharmacovigilance committee has recommended more restrictions on the use of Richter’s Esmya because of concerns over the risk of serious liver damage.

EMA Panel Finalises Safety Probe Into Richter’s Fibroid Drug Esmya

Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.

Keeping Track: Delay (For Celgene), Delay (For Allergan), Goose! (Approval For Lilly)

The latest drug development news and highlights from our US FDA Performance Tracker.

Topics

Related Companies

UsernamePublicRestriction

Register

PS122569

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