Mylan Lawsuit Seeks To Force FDA's Hand On Lipitor Generics
This article was originally published in The Pink Sheet Daily
Executive Summary
Company files for an injunction requiring FDA to announce whether Ranbaxy's atorvastatin ANDA is ineligible for 180-day marketing exclusivity, a determination that could clear the path for approval of other applications starting June 28.
You may also be interested in...
Lipitor Generics Watch: FDA Has Yet To Approve ANDA For The World's #1 Drug
Mylan had pointed to June 28 as the earliest date FDA could approve atorvastatin ANDAs; the agency is continuing discussions with Ranbaxy about its exclusivity status.
Lipitor Generics Watch: FDA Has Yet To Approve ANDA For The World's #1 Drug
Mylan had pointed to June 28 as the earliest date FDA could approve atorvastatin ANDAs; the agency is continuing discussions with Ranbaxy about its exclusivity status.
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: