Pink Sheet is part of the Business Intelligence Division 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


FDA Import Alert Lifted, Apotex Says; Will Lipitor ANDA Approvals Be Far Behind?

Executive Summary

Apotex’s announcement that FDA is lifting an import alert on products manufactured at two Canadian facilities could be interpreted as a good sign for the near-term availability of Lipitor generics, either from first-filer Ranbaxy Laboratories Ltd. or subsequent ANDA filers.

Related Content

Apotex’s Generic Approvals Delayed By FDA Paperwork Snafu, Lawsuit Says
Apotex Seeks Restitution For FDA Import Alert Before World Bank’s Arbitration Arm
India's Race For Lipitor: More Than Five Players May Blunt Generic Gains In Post-Exclusivity Period
Mylan Chairman Robert Coury On Lipitor's Future and India/Japan Expansion: An Interview With PharmAsia News
Talk Of $1 Billion Fine On Ranbaxy By U.S. FDA Dents Stock; Analysts Divided Over Exact Penalty
Lipitor Generics: Questions About Mylan's ANDA Weigh Heavily In Court's Dismissal Of Lawsuit Against FDA
The Last Days Of Lipitor: Morass Of Regulatory, Legal Issues Could Mean Few Early Generics
Lipitor Patent Battle: Pfizer Plots New Course In Suit With Apotex
Apotex Manufacturing Violations Could Delay Launch Of Taxotere Generic
Apotex Manufacturing Violations Could Delay Launch Of Taxotere Generic





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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