Pulzium
Generic name: tedisamil
Treatment for: Atrial Flutter, Atrial Fibrillation
Solvay Pharmaceuticals, Inc. Announces FDA Extension of Tedisamil PDUFA Date
MARIETTA, Ga.--(BUSINESS WIRE)--Sep 26, 2007 - Solvay Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued an extension to the Prescription Drug User Fee Act (PDUFA) deadline in order to complete its review of the New Drug Application (NDA) submitted for tedisamil, an investigational compound for the treatment of recent onset atrial fibrillation or atrial flutter.
The FDA has the option of extending the typical 10-month review period if a sponsor submits a major amendment, as defined by the FDA, during the last three months of the review. In this instance, the company submitted additional clinical pharmacokinetic data. The company has been informed by the FDA that under this revised timeline, it should anticipate action from the FDA on or before January 19, 2008.
In addition, the company has also been requested and plans to participate in the FDA Cardio-Renal Advisory Committee scheduled for December 11-12 to discuss its application.
"We will meet with the FDA to assist them with the review process and participate fully in the upcoming Advisory Committee meeting," said Laurence Downey, M.D., President and CEO, Solvay Pharmaceuticals, Inc. "We strongly believe that tedisamil represents a valuable treatment option for cardiologists treating patients with recent onset atrial fibrillation or flutter."
The NDA submission is based on safety and efficacy studies that evaluated tedisamil for the rapid conversion of recent onset atrial fibrillation or atrial flutter to normal sinus rhythm in more than 1,000 patients with symptomatic atrial fibrillation or flutter. Tedisamil is a class III anti-arrhythmic drug which blocks multiple types of potassium channels.
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com.
Solvay Pharmaceuticals is a research driven group of companies that constitutes 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 www.solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 29,000 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 (NYSE Euronext : SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the NYSE Euronext stock exchange in Brussels. Details are available at www.solvay.com.
Contact
Solvay Pharmaceuticals, Inc.
Neil Hirsch
Manager, U.S. Corporate Communications
770-578-2170
neil.hirsch@solvay.com
Posted: September 2007
Related articles
- Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation - December 13, 2007
- Solvay Pharmaceuticals Files Tedisamil, a New CardiometabolicProduct for the Treatment of Atrial Fibrillation and Atrial Flutter - April 25, 2007
Pulzium (tedisamil) FDA Approval History
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