Original New Drug Application Approvals by US FDA (16-31 December 2024)

07 Jan 2025
Original New Drug Application Approvals by US FDA (16-31 December 2024)
New drug applications approved by US FDA as of 16-31 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.

STEQEYMA
  • Active Ingredient(s): Ustekinumab-stba
  • Strength: 45MG/0.5ML, 90MG/ML / 130MG/26ML
  • Dosage Form(s) / Route(s): Injectable;subcutaneous / Injectable;intravenous
  • Company: Celltrion, Inc.
  • Approval Date: 17 December 2024
  • 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:  17 December 2024 (PDF)
ENSACOVE
  • Active Ingredient(s): Ensartinib Hydrochloride
  • Strength: EQ 25MG BASE; EQ 100MG BASE
  • Dosage Form(s) / Route(s): Capsule;oral
  • Company: Xcovery
  • Approval Date: 18 December 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor.
  • Approved Label:  18 December 2024 (PDF)
TRYNGOLZA (AUTOINJECTOR)
  • Active Ingredient(s): Olezarsen Sodium
  • Strength: EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)
  • Dosage Form(s) / Route(s): Solution;subcutaneous
  • Company: Ionis Pharms Inc
  • Approval Date: 19 December 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
  • Approved Label:  19 December 2024 (PDF)
ALYFTREK
  • Active Ingredient(s): Deutivacaftor; Tezacaftor; Vanzacaftor Calcium
  • Strength: 50MG;20MG;EQ 4MG BASE, 125MG;50MG;EQ 10MG BASE
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Vertex Pharms Inc
  • Approval Date: 20 December 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene.
    If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one indicated mutation.
  • Approved Label:  20 December 2024 (PDF)
ALHEMO
  • Active Ingredient(s): Concizumab-mtci
  • Strength: 60MG/1.5ML(40MG/ML), 150MG/1.5ML(100MG/ML), 300MG/3ML(100MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Subcutaneous
  • Company: Novo Nordisk Inc
  • Approval Date: 20 December 2024
  • Submission Classification: NA
  • Indication(s): Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
    • hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors
    • hemophilia B (congenital factor IX deficiency) with FIX inhibitors
  • Approved Label:  20 December 2024 (PDF)
TEVIMBRA
  • Active Ingredient(s): Tislelizumab-jsgr
  • Strength: 100MG/10ML(10MG/ML)
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Beigene
  • Approval Date: 26 December 2024
  • Submission Classification: NA
  • Indication(s): Indicated for:
      Esophageal Cancer
    • as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
      • Gastric Cancer
    • in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 ( ≥1).
  • Approved Label:  26 December 2024 (PDF)
    • Injectable;injection
OPDIVO QVANTIG
  • Active Ingredient(s): Nivolumab;hyaluronidase-nvhy
  • Strength: 600MG;10000UNITS PER5ML(120MG/2000UNITS PER ML)
  • Dosage Form(s) / Route(s): Injectable;subcutaneous / Injectable;injection
  • Company: Bristol-myers Squibb
  • Approval Date: 27 December 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of:
      • Renal Cell Carcinoma (RCC)
    • adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab.
      • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma.
    • adult patients with advanced RCC, as a first-line treatment in combination with cabozantinib.
    • adult patients with advanced RCC who have received prior anti-angiogenic therapy.
      Melanoma
    • adult patients with unresectable or metastatic melanoma.
    • adult patients with unresectable or metastatic melanoma following combination treatment with intravenous nivolumab and ipilimumab.
      • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma.
    • for the adjuvant treatment of adult patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
      Non-Small Cell Lung Cancer (NSCLC)
    • adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy.
    • adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by OPDIVO QVANTIG monotherapy as adjuvant treatment after surgery.
    • adult patients with metastatic NSCLC and progression on or after platinumbased chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO QVANTIG.
      • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC.
      Squamous Cell Carcinoma of the Head and Neck (SCCHN)
    • adult patients with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy.
      • Urothelial Carcinoma (UC)
    • adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC.
    • adult patients with unresectable or metastatic urothelial carcinoma, as firstline treatment in combination with cisplatin and gemcitabine.
    • adult patients with locally advanced or metastatic UC who:
      • have disease progression during or following platinum-containing chemotherapy.
      • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
      Colorectal Cancer
    • adult patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as monotherapy or as monotherapy following combination treatment with intravenous nivolumab and ipilimumab.a
      • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of MSI-H or dMMR metastatic CRC.
      Hepatocellular Carcinoma (HCC)
    • adult patients with HCC previously treated with sorafenib and following combination treatment with intravenous nivolumab and ipilimumab.a
      • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of HCC.
      Esophageal Cancer
    • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT).
    • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine-and platinum-containing chemotherapy.
      • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC.
    • adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidineand platinum-based chemotherapy.
      Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma
    • adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine-and platinum-containing chemotherapy.
    a 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 trials.
  • Approved Label:  27 December 2024 (PDF)