Teva files ANDA for Fournier/Solvay's fenofibrate
Fournier Laboratories Ireland, a wholly-owned subsidiary of Belgium's Solvay Pharmaceuticals, was informed by Israel-headquartered Teva Pharmaceuticals that it has filed an Abbreviated New Drug Application with a Paragraph IV certification, seeking the approval of a generic version of TriCor (fenofibrate) 145mg NFE tablets in the USA.
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 USA, noted Solvay, adding that Fournier remains fully committed to its fenofibrate franchise and is currently evaluating its options.
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