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Novopharm ranitidine generic should be approved July 10, judge orders FDA.

Executive Summary

NOVOPHARM RANITIDINE APPROVAL EFFECTIVE JULY 10 ORDERED BY FEDERAL JUDGE Terrence Boyle in Raleigh, N.C. court July 3. The judge ruled that FDA's decision granting Genpharm exclusivity for the generic version of Glaxo Wellcome's Zantac was a faulty interpretation of the law. As a result, he ruled that Novopharm's agreement with Glaxo to market the product two weeks before the patent expires is valid.
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