Pharmacia Azulfidine EN-tabs
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Sulfasalazine delayed-release tablets approved Aug. 18 for treatment of polyarticular course juvenile rheumatoid arthritis in patients aged six to 16 who have five or more diseased joints and who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs. The sNDA was supported by a 24-week tria