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Cipher CIP-tramadol NDA in second quarter

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Cipher plans to submit an NDA for its once-daily, sustained-release tramadol formulation in the second quarter, the firm announces Jan. 26. "Cipher has been advised by the FDA that its existing clinical data package meets the requirements to file an NDA," the company reports. The company adds that it has completed enrollment of its ongoing Phase III trial for the product; results will be available in Q3 '06. Cipher has another application pending: its CIP-isotretinoin product has a May 1 user fee date. The firm saw its first drug approval Jan. 11, with the clearance of the cholesterol-lowering agent Lipofen (fenofibrate) via the 505(b)(2) pathway...

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