Original New Drug Application Approvals by US FDA (16-31 May 2025)

23 Jun 2025
Original New Drug Application Approvals by US FDA (16-31 May 2025)
New drug applications approved by US FDA as of 16-31 May 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.

STARJEMZA
  • Active Ingredient(s): Ustekinumab-hmny
  • Strength: 45MG/0.5ML; 130MG/26ML
  • Dosage Form(s) / Route(s): Injectable;subcutaneous
  • Company: Bio-thera Solutions Ltd
  • Approval Date: 22 May 2025
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of:
      Adult patients with:
    • moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy.
    • active psoriatic arthritis (PsA).
    • moderately to severely active Crohn’s disease (CD).
    • moderately to severely active ulcerative colitis.
      Pediatric patients 6 years and older with:
    • moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
    • active psoriatic arthritis (PsA).
  • Approved Label:  22 May 2025 (PDF)
YUTREPIA
  • Active Ingredient(s): Treprostinil Sodium
  • Strength: EQ 0.0265MG BASE/INH; EQ 0.053MG BASE/INH; EQ 0.0795MG BASE/INH; EQ 0.106MG BASE/INH
  • Dosage Form(s) / Route(s): Powder;inhalation
  • Company: Liquidia Tech
  • Approval Date: 23 May 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of:
    • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
    • Pulmonary hypertension associated with interstitial lung disease (PHILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).
  • Approved Label:  23 May 2025 (PDF)
TRYPTYR
  • Active Ingredient(s): Acoltremon
  • Strength: 0.003%
  • Dosage Form(s) / Route(s): Solution/drops;ophthalmic
  • Company: Alcon Labs Inc
  • Approval Date: 28 May 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of the signs and symptoms of dry eye disease.
  • Approved Label:  28 May 2025 (PDF)
KHINDIV
  • Active Ingredient(s): Hydrocortisone
  • Strength: 1MG/ML
  • Dosage Form(s) / Route(s): Solution; Oral
  • Company: Eton
  • Approval Date: 28 May 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency.
      • Limitations of Use
      KHINDIVI is not approved for increased dosing during periods of stress or acute events. Use a different hydrocortisone-containing drug product for stress dosing.
  • Approved Label:  28 May 2025 (PDF)
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
  • Active Ingredient(s): Phenylephrine Hydrochloride
  • Strength: 20MG/250ML (0.08MG/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Sintetica Sa
  • Approval Date: 30 May 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in the setting of anesthesia.
  • Approved Label:  30 May 2025 (PDF)