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June 3, 2022

Will Tirzepatide Slow Kidney Function Decline in Type 2 Diabetes? Will Tirzepatide Slow Kidney Function Decline in Type 2 Diabetes?

Dr Hiddo J.L. Heerspink The twincretin tirzepatide might become part of the arsenal against diabetic kidney disease, new research suggests. Notably, the drug significantly reduced the likelihood […]
June 3, 2022

Prescription Drug Labeling Contact Information

For specific application or supplement questions, please contact For general questions about the Prescribing Information or this website contact the Labeling Policy Team in CDER.  *For the purposes of […]
June 3, 2022

Frequently Asked Questions about Labeling for Prescription Medicines

Boxed Warning (sometimes referred to in lay terms as a “black-box warning”) Contains contraindications or warnings about serious adverse reactions2 that may lead to death or […]
June 3, 2022

Biological Products – Specific Labeling Resources

Biological products, including biosimilar and interchangeable biosimilars, are large and generally complex molecules.  A biological product may weigh more than 800 times than a drug product (e.g., […]
June 3, 2022

Generic Drugs – Specific Labeling Resources

Who Is the Audience for This Website? FDA’s generic drug-specific labeling resources are primarily directed to industry staff who develop generic drug labeling. For more information […]
June 3, 2022

Selection of Appropriate SPL Codes for Human Prescription Drug Labeling

This supplementary webpage is primarily directed to Structured Product Labeling (SPL) developers to assist in selection of appropriate SPL codes for human prescription drug* labeling.  See […]
June 3, 2022

Carton and Container Labeling Resources

On this webpage Who Is the Audience for This Website? FDA’s carton and container labeling specific resources on this webpage are primarily directed to industry staff […]
June 3, 2022

Patient Labeling Resources

On this page Who is the audience for this webpage? FDA’s patient labeling specific resources on this webpage are primarily directed to industry staff who develop […]
June 3, 2022

Prescribing Information Resources

Who is the Audience for This Webpage? FDA’s Prescribing Information (PI) resources on this webpage are primarily directed to industry staff who develop PI. For other […]
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