Pfizer’s Lyrica Gets Split Decision As FDA Raises The Formulation Bar For Generics
This article was originally published in The Pink Sheet Daily
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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