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Cipher reports third quarter fiscal 2007 results
Date:11/7/2007

ble letter

from the U.S. Food and Drug Administration ("FDA") pertaining to

its New Drug Application ("NDA") for CIP-ISOTRETINOIN. The FDA

indicated that the Company's application is approvable subject to

the resolution of two remaining issues. In addition to one

question related to chemistry, manufacturing and controls, the FDA

has requested that the Company provide additional safety data. The

Company believes that the clinical question raised has been

adequately addressed in the NDA submission and has appealed the

position taken by the FDA in its approvable letter using the

formal dispute resolution process. The appeal is ongoing.

CIP-TRAMADOL

On May 3, 2007, the Company received an approvable letter from the

FDA pertaining to its NDA for CIP-TRAMADOL. The FDA indicated that

the Company's application is approvable subject to the resolution

of certain issues, including a request for an additional adequate

clinical trial to provide further efficacy data.

In subsequent discussions with the FDA, the Company has obtained

clarification on the question of efficacy. The FDA has indicated

that the statistical methods used to analyze data from the

Company's clinical trials did not adequately address missing data

relating to subjects who dropped out of the trials. The Company

believes its submission includes sufficient efficacy data to

support regulatory approval.

The Company has a meeting scheduled with the FDA in November 2007

to obtain further clarification on the issues raised in the action

letter. The outcome of these discussions will help the Company

determine the most appropriate path forward to achieve final

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SOURCE Cipher Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
All rights reserved

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