Crestor Generics On Hold As FDA, AstraZeneca Talk About Exclusivity
This article was originally published in The Pink Sheet Daily
Court postpones a decision on a temporary restraining order and asks parties to reach agreement on how FDA is to proceed with pending 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.
Company is waging the same legal battle Otsuka lost last year, arguing pediatric orphan indication should block approvals of ANDAs.
Enrollment-boosting strategy backed by industry rep at Duke-Margolis meeting as FDA official suggests having sponsors develop study plans for pregnant and lactating women with ‘elements of’ the requirement for pediatric studies.