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

FDA Employees Were ‘Granting Approval Without Knowing Why,’ Judge Rules In Ranbaxy Case

This article was originally published in The Pink Sheet Daily

Executive Summary

But court finds FDA has authority to correct its mistakes and revoke Ranbaxy’s tentative ANDA approvals

You may also be interested in...



Sun Pharma’s Ranbaxy Fails In Bid To Dodge Antitrust Suit

A US lawsuit accusing Sun Pharma’s Ranbaxy of violating racketeering and antitrust laws, thereby maintaining artificially inflated prices for three blockbuster drugs, is now set to go to trial in January next year, after a US district court in Massachusetts denied all motions for summary judgment.

With Ranbaxy Under Belt, Sun Eyes Fast Track Global Growth

Sun and Ranbaxy have finally combined into a single global company, but that could be just the beginning of a series of fresh challenges. Sun said it will look at growing its businesses faster than the industry average in most key markets, and at the same time look to remediate the troubled manufacturing sites of Ranbaxy. Management also indicated that it might not appeal against the recent U.S. Court ruling on generic Nexium.

Ranbaxy Exclusivity Implosion Pushes Valcyte Generics Towards Launch; Nexium Remains ‘Very Hazy’

FDA rescinds Ranbaxy’s esomeprazole and valganciclovir ANDA tentative approvals because of GMP compliance issues; firm loses its 180-day marketing exclusivity for valganciclovir but not for esomeprazole.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS078255

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