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BioPharmaceutical United States Legal Issues

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

This article was originally published in The Pink Sheet Daily

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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