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In Brief: Generic ranitidine

Executive Summary

Generic ranitidine: Appeals court will hold emergency hearing July 22 to reconsider July 9 injunction preventing FDA from approving Novopharm's ANDA in time for a July 10 launch ("The Pink Sheet" July 14, T&G-1). Should the stay remain in place, the earliest FDA could theoretically approve a ranitidine ANDA would be Aug. 29 -- the date it determined Genpharm's generic exclusivity period will expire -- unless Genpharm resolves the patent suit brought by Glaxo or licenses its exclusivity to another firm with tentative approval...

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