Scrip is part of the Business Intelligence Division 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

FDA sets 6-month review for antidiabetic Bydureon

This article was originally published in Scrip

Executive Summary

The US FDA has set a PDUFA date of 22 October for the resubmission of Lilly/Amylin/Alkermes's once-weekly GLP-1 receptor agonist Bydureon (extended release exenatide). This represents a longer review period than several analysts had been expecting. Credit Suisse's Catherine Arnold for instance had previously said that the likelihood of a class1, 2-month, review was high.

Advertisement

Related Companies

Advertisement
UsernamePublicRestriction

Register

SC008688

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