Original New Drug Application Approvals by US FDA (16-30 June 2026)

09 Jul 2026
Original New Drug Application Approvals by US FDA (16-30 June 2026)
New drug applications approved by US FDA as of 16-30 June 2026 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

APREPITANT
  • Active Ingredient(s): Aprepitant
  • Strength: 130MG/18ML (7.2MG/ML)
  • Dosage Form(s) / Route(s): Emulsion;intravenous
  • Company: Azurity
  • Approval Date: 16 June 2026
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adults, in combination with other antiemetic agents, for the prevention of:
    • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including highdose cisplatin as a single-dose regimen.
    • delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen.
    • nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.
    Limitations of Use:
    Aprepitant Injectable Emulsion has not been studied for treatment of established nausea and vomiting.
  • Approved Label:  16 June 2026 (PDF)
UTEBZI
  • Active Ingredient(s): Tebipenem Pivoxil Hydrobromide
  • Strength: EQ 300MG BASE
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: GlaxoSmithKline
  • Approval Date: 17 June 2026
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis in adult patients who have limited or no alternative oral treatment options.
    Usage to Reduce Development of Drug-Resistant Bacteria
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of UTEBZI and other antibacterial drugs, UTEBZI should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Approved Label:  17 June 2026 (PDF)
NAVITRUX
  • Active Ingredient(s): Fosaprepitant
  • Strength: 150MG
  • Dosage Form(s) / Route(s): Vial; Single-use
  • Company: Avyxa Holdings
  • Approval Date: 24 June 2026
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of:
    • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including highdose cisplatin.
    • delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
    Limitations of Use
    • NAVITRUX has not been studied for treatment of established nausea and vomiting.
  • Approved Label:  24 June 2026 (PDF)
LUMVOA
  • Active Ingredient(s): Veligrotug-vvze
  • Strength: 500MG/10ML
  • Dosage Form(s) / Route(s): Injection
  • Company: Viridian Therapeutics INC
  • Approval Date: 26 June 2026
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration.
  • Approved Label:  26 June 2026 (PDF)