FDA Referees Tablet Scoring Skirmish: Brand And Generic May Have Different Lines
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.
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Warner Chilcott’s reformulations of Doryx are not anticompetitive, district court finds, but New York AG says its Namenda switching suit is different since there are no alternative interchangeable drugs on the market.
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.
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.