Cipher Appeals FDA's Decision On CIP-T...( Toronto Stock Ex...),Health

Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON, Dec. 4 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has appealed the position taken by the U.S. Food and Drug Administration (FDA) in its approvable letter for CIP-TRAMADOL ER, using the FDA's Formal Dispute Resolution process. Cipher received an approvable letter from the FDA in May 2007 pertaining to its New Drug Application (NDA) for CIP-TRAMADOL ER, the Company's extended-release formulation of tramadol.

"After further dialogue with the FDA over the past several months on the questions raised in the approvable letter, we have determined that the formal dispute resolution process is the most appropriate path forward at this time to achieve final regulatory approval for this product," said Larry Andrews, President and CEO of Cipher.

About Cipher Pharmaceuticals Inc.

Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. The product is being marketed in the United States by ProEthic Pharmaceuticals under the label Lipofen(TM). In addition, Cipher is developing formulations of the pain reliever tramadol and the acne treatment isotretinoin.

Cipher is listed on the Toro
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