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

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

ZEGFROVY
  • Active Ingredient(s): Sunvozertinib
  • Strength: 150MG; 200MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Dizal Jiangsu
  • Approval Date: 2 July 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
    This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Approved Label:  2 July 2025 (PDF)
LYNOZYFIC
  • Active Ingredient(s): Linvoseltamab-gcpt
  • Strength: 5MG/2ML
  • Dosage Form(s) / Route(s): Solution; Injection
  • Company: Rengeneron Pharmaceuticals, Inc.
  • Approval Date: 2 July 2025
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.
    This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
  • Approved Label:  2 July 2025 (PDF)
BENDAMUSTINE HYDROCHLORIDE
  • Active Ingredient(s): Bendamustine Hydrochloride
  • Strength: 100MG/4ML (25MG/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Dr Reddys
  • Approval Date: 3 July 2025
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated treatment of adult patients with:
    • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established.
    • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximabcontaining regimen.
  • Approved Label:  3 July 2025 (PDF)
EKTERLY
  • Active Ingredient(s): Sebetralstat
  • Strength: 300MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Kalvista
  • Approval Date: 3 July 2025
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
  • Approved Label:  3 July 2025 (PDF)
KIRSTY
  • Active Ingredient(s): Insulin Aspart-xjhz
  • Strength: 100 UNITS/ML
  • Dosage Form(s) / Route(s): Injection;solution
  • Company: Biocon Biologics Inc
  • Approval Date: 15 July 2025
  • Submission Classification: NA
  • Indication(s): Indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
  • Approved Label:  15 July 2025 (PDF)