SANOFI-AVENTIS, PRASCO SIGN AGREEMENT FOR ARTHRITIS DRUG
Prasco Laboratories has entered into a distribution and supply agreement with
Aventis Pharmaceuticals, a member of the sanofi-aventis group, to market an
authorized generic version of Aventis' Arava.
There are currently no unexpired patents for Arava (leflunomide) and no generic drugmakers have filed an abbreviated new drug application for leflunomide, according to the FDA's Orange Book.
In 2002, consumer group Public Citizen submitted a petition to the FDA asking the agency to ban Arava because of a suspected link to 12 cases of fatal liver damage. From September 1998, when Arava debuted in the U.S., to September of 2001, the FDA received 130 reports of severe liver reactions in patients taking the drug. An FDA advisory group later recommended the drug stay on the market, saying its benefits outweighed its risks.
In January 2004, Aventis was asked to file a report with the FDA regarding the deaths of five Japanese patients who died during a postmarketing study of the drug in Japan.