Upsher-Smith warning letter
This article was originally published in The Tan Sheet
Executive Summary
Originally posted on FDA's Web site, warning letter for firm's Slo-Niacin supplement was rescinded and eventually removed from site because it had not been approved through appropriate FDA channels, according to counsel for Upsher-Smith. All warning letters are now being reviewed by the agency's Office of Chief Counsel before they are released. 1"The Tan Sheet" Oct. 7, 2002, p. 16 cited a warning letter deeming Slo-Niacin a misbranded new drug...