Unapproved New Drugs
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FDA Roundup: July 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.Competitive Generic Therapy Approvals
Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about approved CGT products and find resources, including a downloadable CGT approvals spreadsheet.Dynamic Blending Specialists, Inc. – 701278 – 06/18/2025
CGMP/Finished Pharmaceuticals/AdulteratedBlendHouse Allerton LLC. Allerton, PA. 483 issued 02/20/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 02/20/2025
Short Title (70 char) BlendHouse Allerton LLC. Allerton, PA. 483 issued 02/20/2025
FEI Number 1921383
Firm Name BlendHouse Allerton LLC
Record Type 483
State PA
Establishment Type ManufacturerEarly Alert: Cardiac Cannula Issue from Medtronic
This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramKorean Aesthetic dba Korean Fillers – 718842 – 11/03/2025
Unapproved New Drugs/Misbranded Botox