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

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

Published: 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...

Source: jdsupra.com
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FDA Issues ROSZET® Statements Letter to Althera Pharmaceuticals - Vimarsana News

FDA Issues ROSZET® Statements Letter to Althera Pharmaceuticals

Published: 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.

Source: natlawreview.com
Related Topics:
United StatesArushi PandyaEli Lilly CompanyBausch Health CompaniesDrug AdministrationOffice Of Prescription Drug PromotionAlthera PharmaceuticalsPrescription Drug PromotionDoctor Info LetterEli LillyMisleading Claims AboutCan Get BelowDelivers PowerfulPrescribing InformationClinical Studies SectionDrug LawsNcreases In Hba1c