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Labopharm once-daily tramadol "approvable" again

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Labopharm received a second "approvable" letter May 30 for the NDA for its once-daily formulation of tramadol, the company said May 31. The new letter is FDA's answer to the December complete response the company submitted to satisfy the initial "approvable" letter it received in September (1Pharmaceutical Approvals Monthly January 2007, In Brief). Labopharm says it will discuss an "appropriate path forward" with FDA, but that it also may proceed with the Formal Dispute Resolution process it initiated in December at the same time it was responding to the September letter. Cipher's competing extended-release tramadol NDA also received an "approvable" letter in May (2Pharmaceutical Approvals Monthly May 2007, In Brief)...

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