An Attempt to Seek Approval for a Generic Version of TriCor® 145mg NFE Tablets
Fournier Laboratories Ireland Ltd, a wholly-owned subsidiary of Solvay Pharmaceuticals, was informed by Teva Pharmaceuticals that it has filed an ANDA - Abbreviated New Drug Application - with a Paragraph IV certification, seeking the approval of a generic version of TriCor® (fenofibrate) 145mg NFE tablets in the United States.
The Paragraph IV certification procedure challenges a number of US patents relating to TriCor® which run through the next decade.
Such procedures are not unusual for branded products in the United States.
Fournier Laboratories Ireland Ltd. remains fully committed to its fenofibrate franchise and is currently evaluating its options.
Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfil 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, visitwww.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 sectors of activity: 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 atwww.solvay.com