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.
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