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

FDA Novel Drug Approvals – October 2023

Nov 012023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Loqtorzi toripalimab-tpzi 10/27/2023 To treat recurrent or metastatic nasopharyngeal

FDA Drug Safety Information for October 25, 2023

Oct 252023
 

Date Brand Name(s) Description Type Reason Company  25-Oct-2023 Exela and Civica Brands Sodium Bicarbonate Injection, USP, Midazolam in 0.8% Sodium Chloride Injection ELCYS (cysteine hydrochloride

FDA Novel Drug Approvals – September 2023

Oct 022023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Rivfloza nedosiran 9/29/2023 To lower urinary oxalate levels in

FDA Novel Drug Approvals – August 2023

Sep 012023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Veopoz pozelimab-bbfg 8/18/2023 To treat patients 1 year old

FDA Novel Drug Approvals – July 2023

Aug 012023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Xdemvy lotilaner 7/25/2023 To treat Demodex blepharitis Vanflyta quizartinib

FDA Novel Drug Approvals – June 2023

Jul 052023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Ngenla somatrogon-ghla 6/27/2023 To treat growth failure due to

FDA Novel Drug Approvals – May 2023

Jun 012023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Inpefa sotagliflozin 5/26/2023 To treat heart failure Drug Trials

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