Original New Drug Application Approvals by US FDA (16-30 August 2023)

01 Sep 2023
Original New Drug Application Approvals by US FDA (16-30 August 2023)
New drug applications approved by US FDA as of 16-31 August 2023 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.

SOHONOS
  • Active Ingredient(s): Palovarotene
  • Strength: 1MG, 1.5MG, 2.5MG, 5MG, 10MG
  • Dosage Form(s) / Route(s): Capsule;oral
  • Company: Ipsen Biopharmaceuticals Inc
  • Approval Date: 16 August 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for reduction in the volume of new heterotopic ossification in adults and children aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).
  • Approved Label:  16 August (PDF)
MELPHALAN HYDROCHLORIDE
  • Active Ingredient(s): Melphalan
  • Strength: 90MG BASE/ML
  • Dosage Form(s) / Route(s): Solution;Intravenous
  • Company: Apopharma A Div Of Apotex Inc
  • Approval Date: 18 August 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
  • Approved Label:  18 August (PDF)
VEOPOZ
  • Active Ingredient(s): Pozelimab-bbfg
  • Strength: 400MG/2ML(200MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Regeneron Pharmaceuticals Inc
  • Approval Date: 18 August 2023
  • Submission Classification: N/A
  • Indication(s): Indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease.
  • Approved Label:  18 August (PDF)
EYLEA HD
  • Active Ingredient(s): Aflibercept
  • Strength: 8MG(0.07ML;114.3MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Regeneron Pharmaceuticals Inc
  • Approval Date: 18 August 2023
  • Submission Classification: N/A
  • Indication(s): Indicated for the treatment of patients with:
    • Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
    • Diabetic Macular Edema (DME)
    • Diabetic Retinopathy (DR)
  • Approved Label:  18 August (PDF)
FOCINVEZ
  • Active Ingredient(s): Fosaprepitant
  • Strength: 150MG/50ML(3MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Spes Pharmaceuticals Inc
  • Approval Date: 22 August 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of:
    • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
    • delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
    Limitations of Use
    FOCINVEZ has not been studied for treatment of established nausea and vomiting.
  • Approved Label:  22 August (PDF)
TYRUKO
  • Active Ingredient(s): Natalizumab-sztn
  • Strength: 300MG/15ML(20MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Sandoz Inc
  • Approval Date: 24 August 2023
  • Submission Classification: N/A
  • Indication(s): Indicated for treatment of:
    Multiple Sclerosis (MS) TYRUKO is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults.Natalizumab products increase the risk of PML. When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk.

    Crohn’s Disease (CD)
    TYRUKO is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α.
    Important Limitations:
    In CD, TYRUKO should not be used in combination with immunosuppressants or inhibitors of TNF-α.
  • Approved Label:  24 August (PDF)