Niacin Supplement For High Cholesterol Targeted In Warning Letter
This article was originally published in The Tan Sheet
Executive Summary
Upsher-Smith Labs' Slo-Niacin was cited by FDA in a recent warning letter for claims it has made to treat hypercholesterolemia
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Upsher-Smith warning letter
Originally posted on FDA's Web site, warning letter for firm's Slo-Niacin supplement was rescinded and eventually removed from site because it had not been approved through appropriate FDA channels, according to counsel for Upsher-Smith.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...
Upsher-Smith warning letter
Originally posted on FDA's Web site, warning letter for firm's Slo-Niacin supplement was rescinded and eventually removed from site because it had not been approved through appropriate FDA channels, according to counsel for Upsher-Smith.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...
Upsher-Smith warning letter
Originally posted on FDA's Web site, warning letter for firm's Slo-Niacin supplement was rescinded and eventually removed from site because it had not been approved through appropriate FDA channels, according to counsel for Upsher-Smith.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...