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:5/23/2016)... Non-invasive diagnostic test realizes the ... ,Technology to be presented at Yissum’s booth, at IATI-BIOMED ... Company of the Hebrew University of Jerusalem announced ... Aurum Ventures MKI, the technology investment arm of Morris ... approach for early detection of multiple diseases by analyzing ...
(Date:5/23/2016)... JERUSALEM , May 23, 2016 ... therapies for the treatment of cancer and orphan genetic ... of up to $4.4 million from the Israel Innovation ... the Israeli Ministry of Economy and Industry. The mission ... and entrepreneurship in various industries, including science and technology, ...
(Date:5/23/2016)... , May 23, 2016   Purdue ... entered into an agreement with Egalet Corporation and ... claims. As part of the agreement the companies ... will enable all three companies to develop and ... "This agreement reflects the commitment of ...
Breaking Medicine Technology:
(Date:5/23/2016)... (PRWEB) , ... May 23, 2016 , ... ... announce the participation of high-level representatives from the Japan PMDA, US FDA, industry ... will address how CDISC standards help format data from clinical trials so that ...
(Date:5/23/2016)... , ... May 23, 2016 , ... ... Texas Veterinary Medical Association (TVMA) reminds pet owners that intervening at the first ... Heatstroke occurs when a pet’s normal body mechanisms cannot keep the body’s temperature ...
(Date:5/23/2016)... Hollywood, California (PRWEB) , ... May 23, 2016 ... ... Luciana Lagana specializes in research on discriminated minorities’ quality of life and ... this purpose, she is creating advocacy documentaries to be tested through research to ...
(Date:5/23/2016)... , ... May 23, 2016 , ... ... on its Chesterfield, Missouri, campus, Standard Process Inc. awarded $6,000 in ... Siewert and Chloe Tillman. Each student is in her fifth trimester of classes ...
(Date:5/23/2016)... ... May 23, 2016 , ... ... to residents of Westchester County for over 24 years, recently hosted its sixth ... members joined HOW for two remembrance ceremonies, each concluding with the release of ...
Breaking Medicine News(10 mins):