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

30 Aug 2024
Original New Drug Application Approvals by US FDA (1-15 August 2024)
New drug applications approved by US FDA as of 1-15 August 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.

VORANIGO
  • Active Ingredient(s): Vorasidenib
  • Strength: 10MG, 40MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Servier
  • Approval Date: 6 August 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection.
  • Approved Label:  6 August 2024 (PDF)
CREXONT
  • Active Ingredient(s): Carbidopa; Levodopa
  • Strength: 35MG;140MG, 52.5MG;210MG, 70MG;280MG, 87.5MG;350MG
  • Dosage Form(s) / Route(s): Capsule, Extended Release;oral
  • Company: Impax
  • Approval Date: 7 August 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.
  • Approved Label:  7 August 2024 (PDF)
ZURNAI (AUTOINJECTOR)
  • Active Ingredient(s): Nalmefene Hydrochloride
  • Strength: EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)
  • Dosage Form(s) / Route(s): Solution;intramuscular, Subcutaneous
  • Company: Purdue Pharma Lp
  • Approval Date: 7 August 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated forfor the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.
  • Approved Label:  7 August 2024 (PDF)
LYMPHIR
  • Active Ingredient(s): Denileukin Diftitox-cxdl
  • Strength: 300MCG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Citius Pharms
  • Approval Date: 7 August 2024
  • Submission Classification: NA
  • Indication(s): Indicated for for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
  • Approved Label:  7 August 2024 (PDF)
NEFFY
  • Active Ingredient(s): Epinephrine
  • Strength: 2mg/spray
  • Dosage Form(s) / Route(s): Spray; Nasal
  • Company: Ars Pharms Operation
  • Approval Date: 9 August 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater.
  • Approved Label:  9 August 2024 (PDF)
YORVIPATH
  • Active Ingredient(s): Palopegteriparatide
  • Strength: EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML); EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML); EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)
  • Dosage Form(s) / Route(s): Solution;subcutaneous
  • Company: Ascendis Pharma Bone
  • Approval Date: 9 August 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of hypoparathyroidism in adults.
      • Limitations of Use:
    • Not studied for acute post-surgical hypoparathyroidism.
    • Titration scheme only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment.
  • Approved Label:  9 August 2024 (PDF)
ENZEEVU
  • Active Ingredient(s): Aflibercept-abzv
  • Strength: 2MG(0.05ML of 40MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Sandoz Inc
  • Approval Date: 9 August 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of patients with:
    • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
  • Approved Label:  9 August 2024 (PDF)
NEMLUVIO
  • Active Ingredient(s): Nemolizumab-ilto
  • Strength: 30MG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Galderma Labs Lp
  • Approval Date: 12 August 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adults with prurigo nodularis.
  • Approved Label:  12 August 2024 (PDF)
LIVDELZI
  • Active Ingredient(s): Seladelpar Lysine
  • Strength: 10MG
  • Dosage Form(s) / Route(s): Capsule;oral
  • Company: Cymabay
  • Approval Date: 14 August 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
    • This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
      Limitations of Use:
      Use of LIVDELZI is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).
  • Approved Label:  14 August 2024 (PDF)
NIKTIMVO
  • Active Ingredient(s): Axatilimab-csfr
  • Strength: 50 MG/ML
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Incyte Corp
  • Approval Date: 14 August 2024
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
  • Approved Label:  14 August 2024 (PDF)