Skip to content

Novel FDA Drug Approvals - 2nd Quarter of 2023 - PharmaKB Report


The Pharmaceutical KnowledgeBase ( provides research and financial intelligence about companies and their approved drugs as well as drug candidates in clinical trials. In this quarterly PharmaKB report, we provide an update about novel drugs approved by the US FDA in of this year.  By referencing new drugs as “novel” the FDA is confirming that the medicine being approved contains ingredients and/or a mechanism of action that the FDA hasn’t previously approved. 

2023 | April | May | June



April 2023 – Novel FDA Drug Approvals




May 2023 – Novel FDA Drug Approvals

Pegunigalsidase alfa  




Nirmatrelvir, ritonavir

  • Drug: Nirmatrelvir, ritonavir
  • Trade name: Paxlovid  
  • Therapeutic Areas: Covid-19 MeSH D000086382; infections MeSH D007239; digestive system diseases MeSH D004066; urogenital diseases MeSH D000091642
  • Manufacturer: Pfizer
  • FDA Approval Date: May 25, 2023
  • Classification: Small molecule
  • Drug Class: Antivirals: HIV protease inhibitors (saquinavir type)
  • Clinical Trials:
  • Adverse Events:
  • Description: Ritonavir is an L-valine derivative that is L-valinamide in which alpha-amino group has been acylated by a [(2-isopropyl-1,3-thiazol-4-yl)methyl]methylcarbamoyl group and in which a hydrogen of the carboxamide amino group has been replaced by a (2R,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl group. A CYP3A inhibitor and antiretroviral drug from the protease inhibitor class used to treat HIV infection and AIDS, it is often used as a fixed-dose combination with another protease inhibitor, lopinavir. Also used in combination with dasabuvir sodium hydrate, ombitasvir and paritaprevir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver. It has a role as an antiviral drug, a HIV protease inhibitor, an environmental contaminant and a xenobiotic. It is a member of 1,3-thiazoles, a L-valine derivative, a carbamate ester, a member of ureas and a carboxamide.
  • FDA News Release:

Flotufolastat F 18




June 2023 – Novel FDA Drug Approvals