Original-New-Drug-Application-Approvals-by-US-FDA--1-15-September-2025

31 Oct 2025
Original-New-Drug-Application-Approvals-by-US-FDA--1-15-September-2025
New drug applications approved by US FDA as of 1-15 September 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.

ZOLYMBUS
  • Active Ingredient(s): Bimatoprost
  • Strength: 0.01%
  • Dosage Form(s) / Route(s): Gel;ophthalmic
  • Company: Thea Pharma
  • Approval Date: 9 September 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
  • Approved Label:  9 September 2025 (PDF)
INLEXZO
  • Active Ingredient(s): Gemcitabine Hydrochloride
  • Strength: EQ 225MG BASE
  • Dosage Form(s) / Route(s): System;intravesical
  • Company: Janssen Biotech
  • Approval Date: 9 September 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
  • Approved Label:  9 September 2025 (PDF)
KOSELUGO
  • Active Ingredient(s): Selumetinib Sulfate
  • Strength: EQ 5 MG BASE; EQ 7.5 MG BASE
  • Dosage Form(s) / Route(s): Granule;oral
  • Company: Astrazeneca
  • Approval Date: 10 September 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
  • Approved Label:  10 September 2025 (PDF)
KOSELUGO
  • Active Ingredient(s): Selumetinib
  • Strength: 10 MG; 25 MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Astrazeneca
  • Approval Date: 10 September 2025
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
  • Approved Label:  10 September 2025 (PDF)