The Food and Drug Administration earlier this month gave final approval to Teva Pharmaceutical's ANDA for fenofibrate capsules (micronized), 134 mg and 200 mg, and has granted tentative approval for the 67 mg strength. A recent U.S. District Court of Illinois decision granted summary judgment of non-infringement regarding Teva's ANDA for this product, which is targeted for treatment of patients with very high elevations of serum triglycerides. As the first generic drug company to file an ANDA with patent certification, Teva is entitled to 180 days of marketing exclusivity. Fenofibrate capsules (micronized) are the AB-rated generic equivalent of Abbott's Tricor capsules.
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COPYRIGHT 2002 Gale Group
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