Lipitor Goes Generic, But First-Filer Ranbaxy’s Approval Leaves Plenty Of Questions In Its Wake
Executive Summary
Ranbaxy launches generic atorvastatin despite not having reached a final settlement with FDA on GMP violations and data integrity issues. Teva’s role in Ranbaxy’s approval and launch is unclear, although the company will get a cut of the first-filer’s profits during the 180-day exclusivity period.
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