Data updated through July 2024
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Zydus Lifesciences Limited – 08/13/2025
Zydus Lifesciences Limited – 08/13/2025. Country: India. Record Type: 483Biosimilar Product Information
This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.FDA Approves First Over-the-Counter Naloxone Nasal Spray
The U.S. Food and Drug Administration approved the first naloxone nasal spray product available without a prescription.Safe Use Initiative – Current Projects
Part of Safe Use Initiative
(updated)Aquastar (USA) Corp Recalls Shrimp Because of Possible Health Risk
October 17, 2025, AquaStar (USA) Corp of Seattle, WA is voluntarily recalling a limited quantity of frozen shrimp imported from Indonesia because they may have been prepared, packed, or held under conditions whereby they may have become exposed to very low levels of cesium-137 (Cs-137).Recently Issued Guidance Documents
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
