FDAnews
www.fdanews.com/articles/80905-teva-s-leflunomide-tablets-approved

TEVA'S LEFLUNOMIDE TABLETS APPROVED

September 14, 2005

Teva Pharmaceutical announced that the FDA has granted final approval for the company's abbreviated new drug application for Leflunomide tablets, 10 mg and 20 mg.

Teva's Leflunomide tablets are the AB-rated generic equivalent of Aventis' Arava tablets and are indicated for treatment of active rheumatoid arthritis to reduce signs and symptoms and to inhibit structural damage.