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

FDA Novel Drug Approvals – March 2023

Apr 032023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Joenja leniolisib 3/24/2023 To treat activated phosphoinositide 3-kinase delta

FDA Novel Drug Approvals – February 2023

Mar 012023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Skyclarys omaveloxolone 2/28/2023 To treat Friedrich’s ataxia Drug Trials

FDA Novel Drug Approvals – January 2023

Feb 012023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Orserdu elacestrant 1/27/2023 To treat estrogen receptor-positive, human epidermal

FDA Novel Drug Approvals – December 2022

Jan 032023
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot NexoBrid anacaulase-bcdb 12/28/2022 To remove eschar in adults with

FDA Novel Drug Approvals – November 2022

Dec 012022
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Tzield teplizumab-mzwv 11/18/2022 To delay the onset of stage

FDA Novel Drug Approvals – October 2022

Nov 012022
 

Drug Name Active Ingredient(s) Approval Date FDA-Approved Use on Approval Date Press Release Drug Trials Snapshot Tecvayli teclistamab-cqyv 10/25/2022 To treat relapsed or refractory multiple

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