Ranitidine Form 1 ANDAs should not have to challenge Form 2, Mylan maintains.
This article was originally published in The Tan Sheet
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.Va.-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) patent, which expires in July, should be otherwise approvable, Mylan maintains.