Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

First-Time Generics Of Sanofi-Aventis’ Arava Enter Market

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA appears to have denied Sanofi’s March citizen petition requesting refusal to approve ANDAs without certain bioequivalence studies.

You may also be interested in...



Was Apokyn Safety Update A Missed Opportunity For Supernus To Hold Off Generic Refill Cartridge?

US FDA told the company to add a warning to the label in late January, about a month before the generic refill cartridge was approved.

Arava, Avandia's Divergent Paths: FDA Strengthens Arava Label Warning

As FDA advisory committee debated the fate of Avandia, the agency bolsters liver warning on Arava, another drug David Graham suggested be removed from the market.

Arava, Avandia's Divergent Paths: FDA Strengthens Arava Label Warning

As FDA advisory committee debated the fate of Avandia, the agency bolsters liver warning on Arava, another drug David Graham suggested be removed from the market.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062878

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