Original New Drug Application Approvals by US FDA (16-30 June 2025)

23 Jul 2025
Original New Drug Application Approvals by US FDA (16-30 June 2025)
New drug applications approved by US FDA as of 16-30 June 2025 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.

ARYNTA
  • Active Ingredient(s): Lisdexamfetamine Dimesylate
  • Strength: 10MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Azurity
  • Approval Date: 16 June 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
    • Moderate to severe binge eating disorder (BED) in adults
      • Limitations of Use:
    • Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older.
    • ARYNTA is not indicated for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of ARYNTA for the treatment of obesity have not been established
  • Approved Label:  16 June 2025 (PDF)
ANDEMBRY
  • Active Ingredient(s): Garadacimab-gxii
  • Strength: 200MG/1.2ML
  • Dosage Form(s) / Route(s): Injectable;subcutaneous
  • Company: Csl Behring Llc
  • Approval Date: 16 June 2025
  • Submission Classification: NA
  • Indication(s): Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
  • Approved Label:  16 June 2025 (PDF)
YEZTUGO
  • Active Ingredient(s): Lenacapavir Sodium
  • Strength: EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)
  • Dosage Form(s) / Route(s): Solution;subcutaneous
  • Company: Gilead Sciences Inc
  • Approval Date: 18 June 2025
  • Submission Classification: NA
  • Indication(s): Indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO.
  • Approved Label:  18 June 2025 (PDF)
YEZTUGO
  • Active Ingredient(s): Lenacapavir
  • Strength: 463.5MG/1.5ML(309MG/ML)
  • Dosage Form(s) / Route(s): Injectable;intravenous, Subcutaneous
  • Company: Gilead Sciences Inc
  • Approval Date: 18 June 2025
  • Submission Classification: NA
  • Indication(s): Indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO.
  • Approved Label:  18 June 2025 (PDF)
YEZTUGO
  • Active Ingredient(s): Lenacapavir Sodium
  • Strength: EQ 300MG BASE
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Gilead Sciences Inc
  • Approval Date: 18 June 2025
  • Submission Classification: NA
  • Indication(s): Indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating YEZTUGO.
  • Approved Label:  18 June 2025 (PDF)
DATROWAY
  • Active Ingredient(s): Datopotamab Deruxtecan-dlnk
  • Strength: 100MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Daiichi Sankyo Inc
  • Approval Date: 23 June 2025
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of:
    • adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
    • This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
    • adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
  • Approved Label:  23 June 2025 (PDF)