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

Dapagliflozin confirms leading role in new diabetes class as FDA accepts NDA

This article was originally published in Scrip

Executive Summary

Bristol-Myers Squibb and AstraZeneca confirmed their leadership position in the type 2 diabetes-focused sodium-glucose cotransporter 2 (SGLT2) inhibitor field with the FDA accepting the partners new drug application for dapagliflozin. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is 28 October, 2011. At the end of January, the European Medicines Agency accepted for review a marketing authorisation application (MAA) for the compound to treat type 2 diabetes. The partners are co-developing the compound under a 2007 deal.

Advertisement

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

SC012147

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