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December 27, 2024

E11A Pediatric Extrapolation

Docket Number: FDA-2022-D-1562 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]
December 25, 2024

Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One Lot of PROGRAF® 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL® 0.5mg (Tacrolimus Extended-Release Capsules) Because Bottles Shipped to U.S. May Contain Empty Capsules

Summary Company Announcement Date: December 23, 2024 FDA Publish Date: December 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Bottles may contain empty […]
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