) has received final United States Food and Drug Administration approval for 67-milligram fenofibrate capsules, the Israeli drugmaker announced yesterday.
The final approval comes five months after tentative approval was granted.
Teva has been marketing 134 mg and 200 mg dosages in the United States since April 2002, after an Illinois court ruled that the company was not in breach of a patent.
Fenofibrate is the generic equivalent of Abbott Laboratories's Tricor, which is used to treat excessive levels of triglycerides in the blood. High levels of triglycerides can cause pancreatitis.
Abbott and Groupe Fournier of Dijon, France received FDA approval for Tricor in February 1998, Dow Jones reports.
Teva is the first company to apply for permission to market the generic version under Paragraph 4, and can therefore be expected to receive 180-day exclusivity in marketing the generic version.
Sales of the 67 mg dose of the original drug are $14 million a year.