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FDA Issues Untitled Letter to Althera Pharmaceuticals for Statements Relating to ROSZET® | Sheppard Mullin Richter & Hampton LLP

June 24, 2022

On June 2, 2022, the US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Althera Pharmaceuticals, LLC (Althera) relating to...

Eli Lilly Company Bausch Health Companies Drug Administration Office Of Prescription Drug Promotion Sheppard Mullin Richter Hampton Althera Pharmaceuticals

Source: jdsupra.com

FDA Issues ROSZET® Statements Letter to Althera Pharmaceuticals

June 23, 2022

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

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FDA Issues Untitled Letter to Althera Pharmaceuticals for Statements Relating to ROSZET&#xAE; | Sheppard Mullin Richter & Hampton LLP

FDA Issues ROSZET&#xAE; Statements Letter to Althera Pharmaceuticals

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FDA Issues Untitled Letter to Althera Pharmaceuticals for Statements Relating to ROSZET® | Sheppard Mullin Richter & Hampton LLP

FDA Issues ROSZET® Statements Letter to Althera Pharmaceuticals