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Pfizer’s Lyrica Gets Split Decision As FDA Raises The Formulation Bar For Generics

This article was originally published in The Pink Sheet Daily

Executive Summary

With Pfizer’s blockbuster pain drug facing numerous generic challengers, the pharma gets FDA to agree not to accept any pregabalin ANDA that would include a “not less than” minimum level for R-isomer impurities; Pfizer’s patent certification arguments fall flat, however.

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