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

Plavix sNDA priority review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb/Sanofi-Aventis' Plavix (clopidogrel) sNDA seeking a claim for treatment of acute ST-segment elevation myocardial infarction (STEMI) has a May 17 PDUFA goal date after being granted priority review status. The sponsors say data from ongoing clinical trials of Plavix in the STEMI setting will be presented at the American College of Cardiology annual meeting in March. The priority designation comes as BMS and Sanofi face patent challenges for the antithrombotic from generic firm Apotex. While BMS believes Plavix' patent expires in 2011, FDA granted final approval to Apotex' generic clopidogrel Jan. 20. "We are vigorously pursuing the pending patent litigation," Bristol CEO Peter Dolan said Jan. 25 during the firm's year-end earnings presentation...

You may also be interested in...



Biden Launches Effort To Strengthen US Pharmaceutical Supply Chain

Executive order calls for short-term and long-term study, broad consultation, coordination with allies.

Cosmetic And Personal Care Trademark Review 23 February, 2021

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

US FDA Commissioner Race Shrinks And Widens: Biden Team Trying To Woo Reluctant Dems On Woodcock While Exploring New Options

White House is trying to overcome some Senate Democrats’ opposition to Janet Woodcock as FDA Commissioner, while also looking for other candidates for the job. Josh Sharfstein, long thought to be Woodcock’s main competition, is not a strong contender.

Topics

UsernamePublicRestriction

Register

OM017301

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