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Ranitidine Form 1 ANDAs should not have to challenge Form 2, Mylan tells FDA in petition.

Executive Summary

RANITIDINE FORM 1 ANDAs SHOULD NOT HAVE TO CHALLENGE FORM 2, Mylan contends in a citizen petition submitted to FDA Jan. 13. The Morgantown, W.V.-based generic company is asking FDA to "distinguish between ranitidine HCl Form 1, and ranitidine HCl Form 2 for the purposes of patent certification." Applications for generic versions of ranitidine Form 1 that contain a paragraph III certification regarding the Form 1 ('658) ranitidine patent, which expires in July, should be approvable, Mylan says.
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