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


Lipitor Generics: FDA Says Mylan Has No Standing To Sue (Until June 28?)

Executive Summary

FDA is using a recent court decision involving ViroPharma’s antibiotic Vancocin to argue for dismissal of a Mylan Pharmaceuticals Inc. lawsuit that seeks a determination on generic marketing exclusivity rights for Pfizer’s Lipitor.

You may also be interested in...

Vancocin Generics Launch As FDA Finds ViroPharma’s Label Fails “Significant New Use” Test

FDA delivers an 87-page chef d'oeuvre that concludes the ViroPharma’s long-running battle to block ANDA approvals. In the citizen petition response, FDA rejects the firm’s scientific and legal arguments and concludes the antibiotic is not eligible for three years of Hatch-Waxman marketing exclusivity under a 2008 law. Although ViroPharma says it plans to sue FDA, the company may have bigger problems on its hands with an FTC investigation.

Lipitor Generics: Ranbaxy Still In The Driver's Seat As Court Dismisses Mylan Lawsuit Against U.S. FDA

Two unresolved factual matters stand in the way of Mylan Pharmaceuticals Inc.' s bid to sue U.S. FDA over generic marketing exclusivity for Pfizer's Lipitor, a U.S. federal judge ruled May 2

Lipitor Generics: Questions About Mylan's ANDA Weigh Heavily In Court's Dismissal Of Lawsuit Against FDA

Judge Boasberg says the court should not "prematurely intrude" on FDA resolution of two factual issues: the approvability of Mylan's atorvastatin ANDA and any generic marketing exclusivity determination involving Ranbaxy.

Related Content


Latest News
See All



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