AstraZeneca Sues FDA On Crestor Generics: Fighting A 'Foregone Conclusion'?
This article was originally published in The Pink Sheet Daily
Company is waging the same legal battle Otsuka lost last year, arguing pediatric orphan indication should block approvals of ANDAs.
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AstraZeneca's legal gambit results in almost two more weeks of sales for the statin even though the court ultimately agreed with FDA on labeling carve-out for orphan indication.
Court postpones a decision on a temporary restraining order and asks parties to reach agreement on how FDA is to proceed with pending ANDAs.