You are here

Generic Equivalent of Avara Receives FDA Nod

WOODCLIFF LAKE, N.J., Sept. 14 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE:BRL) today announced that it's subsidiary, Barr Laboratories, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Leflunomide Tablets, 10 mg & 20 mg, the generic equivalent of Aventis Pharmaceuticals, Inc.'s Arava(R) Tablets, 10 mg & 20 mg. The Company plans to launch its product immediately.

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.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress