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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.

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Apotex Seeks Restitution For FDA Import Alert Before World Bank’s Arbitration Arm

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