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Cipher receives Health Canada approval of Cip-Fenofibrate
Mississauga, Ontario | Tuesday, February 21, 2006, 08:00 Hrs  [IST]

Cipher Pharmaceuticals Inc. has received final approval from Health Canada for CIP-Fenofibrate, the company's novel formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia.

According to the company release, Health Canada has issued a Notice of Compliance for CIP-Fenofibrate which allows for the product to be marketed in Canada. The notification came after the Federal Court of Canada advised the company it would dismiss the legal proceedings brought by Fournier-Pharma Inc. and Laboratoires Fournier S.A. related to the second of two patent issues. The dismissal cleared the path for Health Canada to issue final approval for CIP-Fenofibrate. Cipher announced in January 2006 that it received final approval for CIP-Fenofibrate in the United States from the US Food and Drug Administration.

Larry Andrews, President of Cipher Pharmaceuticals Inc. said, "The approval from Health Canada clears the path to market for CIP-Fenofibrate and will allow ongoing discussions with interested commercial partners for Canada to proceed."

In April 2004, the Therapeutic Products Directorate of the Canadian Health Protection Branch completed its review of Cipher's new drug submission for its novel formulation of CIP-Fenofibrate, and confirmed there were no outstanding review issues. Health Canada approval for CIP-Fenofibrate had been on hold since that time pending the outcome of the legal proceedings.

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