Sanofi US has announced that Winthrop US, its generic division, will begin providing an authorized generic version of Arava tablets indicated for the treatment of active rheumatoid arthritis in adults. Originally approved by the US FDA in 1998, the drug is designed to help improve mobility and reduce joint damage, deformity, pain, and swelling.
Leflunomide, a disease-modifying antirheumatic drug (DMARD), may be used as monotherapy or in combination with other DMARDs or biologics. The authorized generic version will have the identical chemical makeup as the original. The same warnings are in effect, including the contraindication in pregnant women, the need to monitor liver function, and the procedures required for drug elimination when treatment is discontinued.
Cary Yonce, Vice President, General Therapeutics and Life Cycle Management at Sanofi, said, “We are committed to making authorized generics...available and affordable to patients who need them.” He noted that the authorized generic would assure patients that they will receive the same quality treatment as that provided by the original drug.
Sanofi press release. www.news.sanofi.us/2015-10-01-Sanofi-Announces-Launch-of-Authorized-Generic-Version-of-Arava-Leflunomide-Tablets.
Last modified: January 13, 2016