Seroquel Swan Song: AstraZeneca Goes Back To Court After FDA Approves ANDAs
This article was originally published in The Pink Sheet Daily
Executive Summary
Teva and Mylan launch generic versions of Seroquel as AstraZeneca files a second suit to vacate FDA’s approval of their ANDAs after the agency rejected the firm’s clinical data exclusivity plea.
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Court Rules More Trial Data Must Be Posted On ClinicalTrials.gov
Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved drugs will become available under ruling against HHS; co-plaintiff sought eteplirsen study data.
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