June 10, 2024

NDA and BLA Approvals

Please see the list below for available calendar year reports on New Drug Application (NDA) and Biologic License Application (BLA) approvals. Reports Resources Content current as of: 09/29/2017 Regulated […]
June 10, 2024

Resources for Information | Approved Drugs

Drugs@FDAIncludes information about drugs approved for human use in the United States: Drug information, Regulatory history, Most recent FDA-approved Prescribing Information and patient labeling, and Reviews […]
June 10, 2024

Drug Trials Snapshots: ELREXFIO

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
June 7, 2024

FDA Roundup: June 7, 2024

For Immediate Release: June 07, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]
June 7, 2024

Sulbactam and Durlobactam Injection

  Minimum InhibitoryConcentrations (mcg/mL) Disk Diffusion(zone diameters in mm) Pathogen S I R S I R Acinetobacter-baumannii calcoaceticus complex M100 standard is recognized S = Susceptible; […]
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