FDA Issues ROSZET® Statements Letter to Althera Pharmaceuticals
The FDA-approved product labeling (PI) for Roszet includes myopathy, proteinuria and hematuria, and increases in HbA1c and fasting serum glucose levels.
United States Arushi Pandya Eli Lilly Company Bausch Health Companies Drug Administration Office Of Prescription Drug Promotion
Source: natlawreview.com