Navigation Links
Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
Date:12/12/2007

MARIETTA, Ga., Dec. 12 /PRNewswire/ -- Solvay Pharmaceuticals, Inc., announced today that the company will continue to work closely with the U.S. Food and Drug Administration (FDA) to fully address the questions raised by members of the Cardio-Renal Advisory Committee in its meeting to consider tedisamil as a treatment for rapid conversion of recent onset atrial fibrillation to normal sinus rhythm (NSR).

The Committee voted against approval of tedisamil, at this time, requesting that Solvay Pharmaceuticals provides additional information to the Agency. While not binding, the Committee's recommendations will be considered by the FDA in its review of the New Drug Application (NDA) for tedisamil.

"Although we are disappointed with today's vote, we remain committed to working with the FDA to determine appropriate next steps in the review of this drug application," said Laurence Downey, M.D., President and CEO of Solvay Pharmaceuticals, Inc.

The New Drug Application (NDA) for tedisamil was filed with the FDA in December 2006. Following Solvay Pharmaceuticals' submission of additional clinical data amending the NDA for tedisamil, FDA extended the typical 10- month review period. Under this revised timeline, Solvay Pharmaceuticals anticipates action from the FDA on or before January 19, 2008.

About Atrial Fibrillation

Atrial fibrillation (AFib) is an abnormal heart rhythm, known as a cardiac arrhythmia, affecting the upper chambers of the heart (atria). In this condition, the electrical signals in the atria that are responsible for directing the activity of the lower chambers of the heart (ventricles) become unsynchronized, and the ventricles continue pumping, usually irregularly and rapidly. This fast, uncoordinated rhythm prevents the heart from efficiently pumping blood out to the body. Some heart conditions associated with AFib include hypertension, heart failure, and coronary artery disease.

AFib -- the most common clinically relevant arrhythmia with an overall prevalence that increases with age -- affects more than 2 million adults in the U.S. This common sustained cardiac rhythm disorder is associated with substantial mortality and morbidity from stroke, thromboembolism and heart failure.

About Solvay Pharmaceuticals, Inc.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit http://www.solvaypharmaceuticals-us.com.

Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology, and men's and women's health. Its 2006 sales were EUR 2.6 billion and it employs approximately 10,000 people worldwide. For more information, visit http://www.solvaypharmaceuticals.com.

SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 30,000 people in 50 countries. In 2006 its consolidated sales amounted to EUR 9.4 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY (Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the Euronext stock exchange in Brussels.

Details are available at http://www.solvay.com.


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

Related medicine technology :

1. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
2. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
3. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
4. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
5. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
6. Symbollon Pharmaceuticals, Inc. Evaluates the Clinical Effects of IoGen(TM) on Fibrocystic Breast Disease
7. Aegerion Pharmaceuticals, Inc. Presents Final Results of Phase II Clinical Trials for AEGR-733 at Drugs Affecting Lipid Metabolism (DALM) 2007 Conference
8. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
9. Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans
10. Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
11. FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 2017  South Korean-based healthcare product Development Company I.M. ... on Kickstarter. The device will educate the user about ... better efficiency compared to the dated and pricey CPR ... efficacy of the compression for a more informed CPR ... to raise $5,000. ...
(Date:10/2/2017)... INDIANAPOLIS , Oct. 2, 2017  Eli Lilly ... its financial results for the third quarter of 2017 ... a conference call on that day with the investment ... performance. The conference call will begin at ... public can access a live webcast of the conference ...
Breaking Medicine Technology:
(Date:10/13/2017)... Calif. (PRWEB) , ... October 13, 2017 , ... Many ... dementia. However, many long-term care insurance companies have a waiver for care if the ... 90-day elimination period, when the family pays for care, is often waived, so the ...
(Date:10/13/2017)... ... ... Talented host, actor Rob Lowe, is introducing a segment ... of "Success Files," which is an award-winning educational program broadcasted on PBS Member ... with passion and integrity. , Sciatica occurs when the sciatic nerve in the ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... treating sleep apnea using cutting-edge Oventus O2Vent technology. As many as ... disorder characterized by frequent cessation in breathing. Oral appliances can offer significant relief ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... in post-acute health care, have expanded their existing home health joint venture through ... AccentCare has been operating a joint venture home health company with Asante, delivering ...
(Date:10/12/2017)... Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... is holding a treadmill relay – Miles by Moonlight to raise money for the ... donating $300 or more. , Teams will work together to keep their treadmills ...
Breaking Medicine News(10 mins):