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Teva’s Generic Irbesartan Deserves 180-Day Exclusivity Because Of Review Delays, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Lupin Pharmaceuticals had filed a citizen petition arguing that Teva was not entitled to the first-mover 180-day exclusivity because it failed to get tentative approval within 30 months, but FDA said that it had changed its criteria and requested additional testing.

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