FDA Novel Drug Approvals – January 2025

Feb 012025
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Journavx suzetrigine 1/30/2025 To treat moderate to severe acute

FDA Drug Safety Information for January 31, 2025

Jan 312025
 

Date Brand Name(s) Description Type Reason Company  1/31/2025 Alvogen Fentanyl Transdermal System 25 mcg/h transdermal patches Drugs There is potential that patches could be multi-stacked,

FDA Drug Safety Information for January 30, 2025

Jan 302025
 

Date Brand Name(s) Description Type Reason Company  1/30/2025 Olympus MAJ-891 endoscope accessory Medical Devices Risk of device contamination that may result from improper reprocessing. Olympus

Updated Drug Shortage Information for January 28, 2025

Jan 282025
 

New Shortages January 28, 2025 Donepezil Hydrochloride Tablet (Discontinuation) Lidocaine Ointment (Discontinuation) Teriflunomide Tablet (Discontinuation) Shortage Updates January 28, 2025 Amoxapine Tablet (Resolved)

Updated Drug Shortage Information for January 27, 2025

Jan 272025
 

New Shortages January 27, 2025 Bendamustine Hydrochloride Injection (Discontinuation) Shortage Updates January 27, 2025 Atropine Sulfate Injection (Currently In Shortage) Bupivacaine Hydrochloride Injection (Currently In Shortage) Bupivacaine Hydrochloride,

FDA Drug Safety Information for January 24, 2025

Jan 242025
 

Date Brand Name(s) Description Type Reason Company  01/24/2025 Provepharm Inc. Phenylephrine hydrochloride Injection, USP, 10 mg/ mL Drugs Device & Drug Safety – Potential Foreign

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