FDA Novel Drug Approvals – November 2023

Dec 012023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Ogsiveo nirogacestat 11/27/2023 To treat adults with progressing desmoid

FDA Drug Safety Information for November 27, 2023

Nov 272023
 

Date Brand Name(s) Description Type Reason Company  27-Nov-2023 Novartis Sandimmune (cyclosporine oral solution, USP) Oral Solution 100 mg/mL Drugs Due to crystallization formation Novartis Pharmaceuticals

FDA Drug Safety Information November 21, 2023

Nov 212023
 

Date Brand Name(s) Description Type Reason Company  21-Nov-2023 Bayer Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles Drugs Microbial contamination identified as Penicillium

FDA Drug Safety Information for November 17, 2023

Nov 172023
 

Date Brand Name(s) Description Type Reason Company  17-Nov-2023 KinderMed OTC Pain and Fever Reliever for Infants and Kids Drugs Due to Acetaminophen Instability KinderFarms, LLC

FDA Drug Safety Information for November 15, 2023

Nov 152023
 

Date Brand Name(s) Description Type Reason Company  15-Nov-2023 Multiple brands Lubricant Eye Drops & Multi-Symptom Eye Drops Drugs Device & Drug Safety Potential Safety Concerns

FDA Drug Safety Information for November 6, 2023

Nov 062023
 

Date Brand Name(s) Description Type Reason Company  6-Nov-2023 Multiple brand names 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Medical Devices Lack

FDA Drug Safety Information for November 1, 2023

Nov 012023
 

Date Brand Name(s) Description Type Reason Company  1-Nov-2023 LEADER OTC Ophthalmic Sterile Drops Drugs Insanitary manufacturing conditions Cardinal Health, Inc. 1-Nov-2023 Rugby OTC Ophthalmic Sterile

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