Medical Letter on the CDC & FDA
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC & FDA
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Drug Development
U.S. FDA grants approval for Leflunomide for rheumatoid arthritis
October 23rd, 2005
Barr Pharmaceuticals, Inc., (BRL) 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 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...
Source: Medical Letter on the CDC & FDA (2005-10-23)
|
