Purepac Challenges Andrx Cardia XT Exclusivity On Reformulation Grounds
Executive Summary
A first-to-file ANDA applicant should lose its eligibility for 180-day exclusivity if it makes major changes to the application at a later date, Purepac asserts in a petition to FDA requesting that Andrx be stripped of its exclusivity for generic sustained-release diltiazem, equivalent to Hoechst Marion Roussel's Cardizem CD.
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