Toronto Stock Exchange Symbol: DND

- Company receives US$1.0 million milestone -

- Company also files New Drug Submission with Health Canada -

MISSISSAUGA, ON, Dec. 21, 2011 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that its amendment to the New Drug Application (NDA) for CIP-ISOTRETINOIN, a novel, patented formulation of the acne medication isotretinoin, has been accepted by the U.S. Food and Drug Administration (FDA) as a complete, class 2 response. The FDA's goal date under the Prescription Drug User Fee Act (PDUFA) is May 29, 2012.

Cipher will receive a US$1.0 million milestone payment from its marketing partner by year-end, which was triggered by FDA acceptance as a complete response.

Cipher also announced that it has submitted a New Drug Submission with Health Canada for CIP-ISOTRETINOIN.

About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a growing specialty pharmaceutical company that commercializes novel formulations of successful, currently marketed molecules. Cipher's strategy is to in-license clearly differentiated products, advance them through the clinical development and regulatory approval stages, and out-license to international marketing partners. The Company's first product is a fenofibrate formulation marketed in the United States as Lipofen®. Cipher's second product, an extended-release tramadol, is marketed in the United States as ConZip™ and will be marketed in Canada as Durela™. Cipher's New Drug Application for its third product, a novel formulation of the acne treatment isotretinoin, is currently being reviewed by the FDA.

Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding.  For more information, please visit www.cipherpharma.com.

Forward-Looking Statements

Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. The words "may", "will", "could", "should", "would", "suspect", "outlook", "believe", "plan", "anticipate", "estimate", "expect", "intend", "forecast", "objective", "hope" and "continue" (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements.  Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.