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 thromboembolic
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Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/14/2025
Short Title (70 char) Empower Clinic Services LLC dba Empower Pharma. Houston, TX. 483 issued 12/14/2025
FEI Number 3011887629
Firm Name Empower Clinic Services LLC dba Empower Pharma
Record Type 483Somerset Therapeutics Private Limited – 711340 – 09/04/2025
CGMP/Finished Pharmaceuticals/Adulterated