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June 4, 2022

‘Profound’ Results With Ibrutinib Add-On in Mantle Cell Lymphoma ‘Profound’ Results With Ibrutinib Add-On in Mantle Cell Lymphoma

Dr Michael Wang The largest trial to date in mantle cell lymphoma shows that adding the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib (Imbruvica) to standard of […]
June 4, 2022

Worried About Which COVID-19 Vaccine is Better? Study Finds Getting Three Doses is Key

Three doses of any combination of COVID-19 vaccines work similarly well at preventing infection and hospitalization, research shows. With the appearance of the Omicron variants, three […]
June 3, 2022

Trauma Surgeons Offer Tips to Address Gun Violence Trauma Surgeons Offer Tips to Address Gun Violence

Trauma surgeons are in the tough position of seeing victims just after gun violence across the United States, and they have some advice. Their strategies can […]
June 3, 2022

CDC Identifies Two Monkeypox Strains in US CDC Identifies Two Monkeypox Strains in US

At least two strains of monkeypox are currently circulating in the United States, officials from the Centers for Disease Control and Prevention (CDC) said Friday. Most […]
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 […]
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