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Generic Equivalent of Avara Receives FDA Nod
The New Chemical Entity exclusivity for Arava expired in September 2003. Aventis was also granted a pediatric exclusivity on Arava, which expired in March 2004. Other exclusivities on Arava do not affect Barr's ability to manufacture and market its generic product.
Barr's Leflunomide Tablets, 10 mg & 20 mg, are indicated in adults for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms and to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing.
Barr's Leflunomide Tablets, 10 mg & 20 mg, will compete in a market that had total combined annual sales of approximately $238 million, based on IMS sales data for the twelve months ended July 2005.
Source: Barr Pharmaceuticals, Inc.