FDA rejects Labopharm’s tramadol appeal
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Labopharm will persist in pursuing FDA's dispute resolution process with an appeal to the next supervisory level in the coming weeks, the company says after the agency rejected an appeal seeking approval of its once-daily tramadol NDA based on existing data. FDA responded to the appeal but did not overturn its May "approvable" decision, the company announces Nov. 21. Labopharm entered FDA's formal dispute resolution process in October after receiving two approvable letters for its once-daily tramadol; the agency asserted that the NDA's statistical method did not address missing information related to subjects who dropped out of the trials (1Pharmaceutical Approvals Monthly, October 2007, p. 32). In a meeting after the second letter, FDA indicated that an additional Phase III trial might be necessary to meet statistical requirements. Analysis of missing data from dropouts has also emerged as an issue in the review of Cipher's once-daily tramadol formulation, CIP-tramadol ER, which also received an approvable letter in May...
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