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Geneva seeks six-month exclusivity on ranitidine form 1; Novopharm expects marketing plans to proceed.

Executive Summary

GENEVA SEEKING 180-DAY EXCLUSIVITY FOR FORM 1 RANITIDINE in a citizen petition submitted to FDA May 21. In the petition, Geneva asks FDA to confirm that Geneva is considered the first to submit a form 1 ranitidine ANDA containing a "Paragraph IV" certification, which would give Geneva six-month marketing exclusivity for the generic. Geneva's ranitidine ANDA was submitted in January 1994 and tentatively approved in January 1996.
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PS030248

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