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AstraZeneca sues FDA with 'poison pill' attack; claims Seroquel warnings are its IP

This article was originally published in Scrip

Executive Summary

In a case that might start to explain why it can take until near the end of a drug's patented lifetime to define and recognise some of its adverse effects, AstraZeneca has filed a lawsuit against the US FDA in a last-ditch attempt to keep generic Seroquel (quetiapine fumarate) off the market until December. The pharma company is hoping to overturn the agency's recent decision not to delay approval of generic versions of its best-selling anti-depressant.

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