Can Warner Chilcott Run Up The Scores On Generics?
This article was originally published in The Pink Sheet Daily
Success of petition seeking to block single-scored generics of Doryx will likely rest on the brand firm's ability to make a safety and efficacy case for its dual-scored version of the antibiotic, which may be difficult given that it was marketed as a single-scored tablet for so long.
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On Aug. 9, FDA’s Pharmaceutical Science and Clinical Pharmacology panel will discuss the agency’s year-old draft guidelines on the data needed to support functional scoring of tablets. Issues related to tablet scoring as a purported strategy for delaying generic entry are at the heart of Mylan’s recent lawsuit against Doryx marketer Warner Chilcott.
Warner Chilcott didn’t address the elephant in the room – a potential acquisition – during its first quarter earnings call.
FDA denied Warner Chilcott’s citizen petition requesting the agency not approve ANDAs referencing Doryx unless they were for dual-scored tablets; Mylan must make change from single-score in its second manufacturing run.