Navigation Links
Cipher Appeals FDA's Decision On CIP-TRAMADOL ER
Date:12/4/2007

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 Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit http://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. Some forward-looking statements may be identified by words like "may", "will", "anticipate", "estimate", "expect", "intend", or "continue" or the negative thereof or similar variations. 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. The Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.


'/>"/>
SOURCE Cipher Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Cipher reports third quarter fiscal 2007 results
2. First Circuit Court of Appeals Rules Against Philip Morris in Lights Class Action
3. NBME Appeals Massachusetts Judges Reversal of Lower Court in Suit for Extra Break Time During Medical Licensing Exam
4. Labopharm appeals FDAs decision on once-daily tramadol
5. Gerresheimer to be Included in the SDAX Early Decision on Inclusion in the MDAX on September 5, 2007
6. Microarray provides 3 genomic guides to breast cancer treatment decisions
7. Spectranetics to Appeal Decision in Patent Litigation
8. Canadas government funds $1.6M in modern geography to support public health decisions
9. Parents participation in medical decisions linked to self-efficacy
10. Decision-making by residents on-call has miniscule negative impact on patient care
11. Political decisions harming cancer treatment in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... SC (PRWEB) , ... May 27, 2016 , ... ... a line of classic American timber frame barn kits, which can be found on ... are inspired by historic American barn plans, and they highlight the craftsmanship of timber ...
(Date:5/27/2016)... ... ... An influential resource amongst nurses and professionals in the health care world, ... of topics detailing why we appreciate nurses in so many different ways. From exclusive ... being in a major recession to one of the hottest growing professions in any ...
(Date:5/27/2016)... ... May 27, 2016 , ... An ... bolstered by inspiring human-interest stories, courtesy of awareness-driven celebrities and thought leaders. It ... leading advocates, associations and industry leaders such as Bioness. , As patients ...
(Date:5/27/2016)... , ... May 27, 2016 , ... ... installment is bolstered by inspiring human interest stories, courtesy of leaders in the ... and tech within the industry, from leading advocates and associations—namely Jones & Bartlett ...
(Date:5/27/2016)... ... May 27, 2016 , ... ... the pharmaceutical, medical and food industries. Aside from its GMP accreditation, Validation Center ... proof of successfully certified products, services and staff. , Validation Center is ISO17025 ...
Breaking Medicine News(10 mins):
(Date:5/25/2016)... -- MedDay, a biotechnology company focused on the ... entitled "High doses of biotin in progressive multiple sclerosis: extension ... Professor Ayman Tourbah , Principal Investigator of the Phase ... of Neurology (EAN) in Copenhagen, Denmark . ... place on Sunday, 29 May 2016 from 14:45 to 16:15 ...
(Date:5/24/2016)... 2016 Niederländische Chirurgen haben ... es Ärzten erlaubt, ihre Expertise weltweit zu teilen ... Live Streaming mit einer Instant-Messaging-Funktion und der Möglichkeit, ... in Europa, Afrika, Asien und den ... Plattform registriert. Information und Weiterbildung   ...
(Date:5/24/2016)...   , Study met both ... superiority in , Excellent plus Good ... of the ascending colon   , ... today announced new positive data from the phase III MORA study ... 2 litre PEG with ascorbate. The study met both primary endpoints ...
Breaking Medicine Technology: