FDA Must Act Quickly On Ranbaxy Lipitor ANDA: Mylan

Law360 (April 28, 2011, 6:54 PM EDT) -- Mylan Pharmaceuticals Inc. asked a Washington federal judge on Thursday not to toss its suit seeking to compel the U.S. Food and Drug Administration to remove the exclusivity provision from Ranbaxy Laboratories Ltd.'s dormant first-filed abbreviated new drug application for Lipitor.

Ranbaxy, the first to challenge Pfizer Inc.'s patents on Lipitor when it filed its ANDA nine years ago, argues it has 180 days of exclusivity beginning in November to sell a generic version of the blockbuster cholesterol drug, known generically as atorvastatin. But Mylan, which...
To view the full article, register now.

Related

Sections

Case Information

Case Title

MYLAN PHARMACEUTICALS INC. et al v. UNITED STATES FOOD AND DRUG ADMINISTRATION


Case Number

1:11-cv-00566

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

James E. Boasberg

Date Filed

March 18, 2011

Law Firms

Companies

Government Agencies

Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.