FDA Novel Drug Approvals – December 2024

Jan 012025
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Alhemo concizumab-mtci 12/20/2024 For routine prophylaxis to prevent bleeding

FDA Drug Safety Information for December 24, 2024

Dec 242024
 

Date Brand Name(s) Description Type Reason Company  12/24/2024 Astellas Tacrolimus and Tacrolimus Extended-Release capsules Drugs Bottles may contain empty capsules. Astellas Pharma US, Inc.

FDA Drug Safety Information for December 20, 2024

Dec 202024
 

Date Brand Name(s) Description Type Reason Company  12/20/2024 Par Pharmaceutical Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) Drugs Product is an unapproved drug. Endo, Inc.

Updated Drug Shortage Information for December 19, 2024

Dec 192024
 

Shortage Updates December 19, 2024 Bupivacaine Hydrochloride Injection (Currently In Shortage) Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection (Currently In Shortage) Dextrose Monohydrate 25% Injection (Resolved) Dextrose Monohydrate 50% Injection (Currently

Updated Drug Shortage Information for December 10, 2024

Dec 102024
 

New Shortages December 10, 2024 Adalimumab-Adbm Injection (Discontinuation)   December 9, 2024 Lodoxamide Tromethamine Solution (Discontinuation) Tiagabine Hydrochloride Tablet (Discontinuation) Tigecycline Injection (Discontinuation)   December 6, 2024 Sodium Chloride

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