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

02 Dec 2025
Original New Drug Application Approvals by US FDA (16-31 October 2025)
New drug applications approved by US FDA as of 16-31 October 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.

FERABRIGHT
  • Active Ingredient(s): Ferumoxytol
  • Strength: EQ 300MG IRON/10ML (EQ 30MG IRON/ML); EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Covis
  • Approval Date: 16 October 2025
  • Submission Classification: NA
  • Indication(s): Indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted bloodbrain barrier.
  • Approved Label:  16 October 2025 (PDF)
EPIOXA HD/EPIOXA KIT
  • Active Ingredient(s): Riboflavin 5'-phosphate
  • Strength: 0.239%;0.177%
  • Dosage Form(s) / Route(s): Solution/drops;ophthalmic
  • Company: Glaukos
  • Approval Date: 17 October 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for use in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O2n System and the Boost Goggles.
  • Approved Label:  17 October 2025 (PDF)
CONTEPO
  • Active Ingredient(s): Fosfomycin Disodium
  • Strength: EQ 6GM BASE/VIAL
  • Dosage Form(s) / Route(s): Powder;intravenous
  • Company: Meitheal
  • Approval Date: 22 October 2025
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including acute pyelonephritis caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae.
    • Usage to Reduce Development of Drug-Resistant Bacteria
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of CONTEPO and other antibacterial drugs, CONTEPO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
  • Approved Label:  22 October 2025 (PDF)
DEHYDRATED ALCOHOL
  • Active Ingredient(s): Alcohol
  • Strength: 98%(5ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Royal Pharms
  • Approval Date: 23 October 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of methanol poisoning in combination with hemodialysis in adults.
  • Approved Label:  23 October 2025 (PDF)
JAVADIN
  • Active Ingredient(s): Clonidine Hydrochloride
  • Strength: 0.02MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Azurity
  • Approval Date: 23 October 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of hypertension in adult patients to lower blood pressure. Lowering blood pressure has been shown to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Approved Label:  23 October 2025 (PDF)
BLENREP
  • Active Ingredient(s): Belantamab Mafodotin-blmf
  • Strength: 70MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Glaxosmithkline Llc
  • Approval Date: 23 October 2025
  • Submission Classification: NA
  • Indication(s): Indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
  • Approved Label:  23 October 2025 (PDF)
ROCURONIUM BROMIDE
  • Active Ingredient(s): Rocuronium Bromide
  • Strength: 50MG/5ML (10MG/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Sterinova Inc
  • Approval Date: 24 October 2025
  • Submission Classification: NA
  • Indication(s): Indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
  • Approved Label:  24 October 2025 (PDF)
LYNKUET
  • Active Ingredient(s): Elinzanetant
  • Strength: 60MG
  • Dosage Form(s) / Route(s): Capsule;oral
  • Company: Bayer Hlthcare
  • Approval Date: 24 October 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
  • Approved Label:  24 October 2025 (PDF)