Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Mylan Sues FDA Alleging Inaction And Failure To Share Clarity On Ranbaxy's Atorvastatin Filings

This article was originally published in PharmAsia News

Executive Summary

MUMBAI - Two months after settling a patent litigation with Pfizer Inc. for cholesterol-reducing agent Lipitor (atorvastatin), generic drugs major Mylan Pharmaceuticals Inc. has charged that U.S. FDA's failure to decide and disclose critical information related to Ranbaxy Laboratories' Ltd. abbreviated new drug application for atorvastatin is "unlawful, arbitrary and capricious.

You may also be interested in...



Talk Of $1 Billion Fine On Ranbaxy By U.S. FDA Dents Stock; Analysts Divided Over Exact Penalty

MUMBAI - Shares of Ranbaxy Laboratories Ltd., listed on the Indian stock exchanges, plunged 6% May 5 to 426 Indian Rupees ($9.48) per share, reacting sharply to a Fortune magazine report that claimed the company may be fined over $1 billion as part of a protracted negotiation and settlement process with U.S. FDA

Talk Of $1 Billion Fine On Ranbaxy By U.S. FDA Dents Stock; Analysts Divided Over Exact Penalty

MUMBAI - Shares of Ranbaxy Laboratories Ltd., listed on the Indian stock exchanges, plunged 6% May 5 to 426 Indian Rupees ($9.48) per share, reacting sharply to a Fortune magazine report that claimed the company may be fined over $1 billion as part of a protracted negotiation and settlement process with U.S. FDA

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

Related Content

UsernamePublicRestriction

Register

SC077437

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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