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FDA Referees Tablet Scoring Skirmish: Brand And Generic May Have Different Lines

 
• By Brenda Sandburg

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.

FDA thoroughly rejected Warner Chilcott’s attempt to block approval of a generic version of its antibiotic Doryx (doxycycline) on the grounds the generic tablet is not dual scored. The agency asserted that there is little chance that marketing a single-scored tablet concurrently with a dual-scored tablet for a limited period of time would lead to a safety issue.

Warner Chilcott filed a citizen petition on Sept. 23 asking the agency not to approve any doxycycline 150 mg dose...

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