AstraZeneca launches pre-emptive lawsuit against FDA over generic Crestor approval

30 June 2016

Earlier this week, iPR Pharmaceuticals, the owner of NDA 021366 for Crestor (rosuvastatin calcium) and Anglo-Swedish pharma major AstraZeneca (LSE: AZN), which markets the cholesterol drug, filed a Complaint a in the US District Court for the District of Columbia seeking to block the US Food and Drug Administration’s approval of Abbreviated New Drug Applications (ANDAs) for generic Crestor tablets.

The moves comes ahead of the July 8 date when many in industry had been anticipating approval (including AstraZeneca, which says that it’s a “foregone conclusion”), says Kurt Karst, writing on Hyman, Phelps & McNamara’s FDA Law Blog.

Crestor is AstraZeneca’s best-selling drug, generating about $5 billion of its total $23.6 billion in product sales last year. About $2.8 billion worth of sales come from the USA.

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