Original New Drug Application Approvals by US FDA (1-15 December 2024)

20 Dec 2024
Original New Drug Application Approvals by US FDA (1-15 December 2024)
New drug applications approved by US FDA as of 1-15 December 2024 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.

BIZENGRI
  • Active Ingredient(s): Zenocutuzumab-zbco
  • Strength: 375MG/18.75ML
  • Dosage Form(s) / Route(s): Injection;solution
  • Company: Merus N.v.
  • Approval Date: 4 December 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of:
    • Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.*
    • Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.*
    * 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 a confirmatory trial(s).
  • Approved Label:  4 December 2024 (PDF)
CRENESSITY
  • Active Ingredient(s): Crinecerfont
  • Strength: 25MG; 50MG; 100MG
  • Dosage Form(s) / Route(s): Capsule;oral
  • Company: Neurocrine
  • Approval Date: 13 December 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).
  • Approved Label:  13 December 2024 (PDF)
CRENESSITY
  • Active Ingredient(s): Crinecerfont
  • Strength: 50MG/ML
  • Dosage Form(s) / Route(s): Solution;oral
  • Company: Neurocrine
  • Approval Date: 13 December 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).
  • Approved Label:  13 December 2024 (PDF)
NEMLUVIO
  • Active Ingredient(s): Nemolizumab-ilto
  • Strength: 30mg
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Galderma Labs Lp
  • Approval Date: 13 December 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.
  • Approved Label:  13 December 2024 (PDF)
UNLOXCYT
  • Active Ingredient(s): Cosibelimab-ipdl
  • Strength: 300MG/5ML(60MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Checkpoint Therapeutics Inc
  • Approval Date: 13 December 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
  • Approved Label:  13 December 2024 (PDF)