Ortho Tri-Cyclen Label Being Revised To Add Lack Of Effect On Bone Density In Anorexics
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA approves Ortho Tri-Cyclen label change stating product did not produce significant difference in total bone mineral density versus placebo for anorexic adolescent females during one-year trial. J&J will update label following negotiations over additional "unrelated" label changes.