FDA has determined that a REMS is no longer necessary to ensure ERA medicines’ benefits outweigh the risk of EFT.
Similar Posts
Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication
Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolicSearch List of Extended Use Dates to Assist with Drug Shortages
This is to update and consolidate the extended use date information posted previously to assist with drug shortage (6/15/17 to present).Kath Khemicals LLC – 711699 – 09/22/2025
CGMP/Finished Pharmaceuticals/AdulteratedSprout Organics Expands Voluntary Recall of Sweet Potato Apple and Spinach to Include Additional Lot Codes
Sprout Organics is expanding its September 16, 2025 recall of Sprout Organics® Sweet Potato Apple and Spinach, due to potentially elevated lead levels, to include additional lots.Sun Pharmaceuticals Medicare Ltd. 9/19/2025
Record Date: 9/19/2025
Entity Name: Sun Pharmaceuticals Medicare Ltd.
FEI Number: 3002957541
Record Type: 483
Country: India
Establishment Type: Sterile Drug ManufacturerUpdate on Alert: Infusion Set Performance Issue from BD
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.