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

13 Dec 2023
New drug applications approved by US FDA as of 16-30 November 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.

TRUQAP
  • Active Ingredient(s): Capivasertib
  • Strength: 160MG, 200MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Astrazeneca Pharms
  • Approval Date: 16 November 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated, in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
  • Approved Label:  16 November 2023 (PDF)
RYZNEUTA
  • Active Ingredient(s): Efbemalenograstim Alfa-vuxw
  • Strength: 20MG/ML
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Evive Biotechnology
  • Approval Date: 16 November 2023
  • Submission Classification: N/A
  • Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • Approved Label:  16 November 2023 (PDF)
OGSIVEO
  • Active Ingredient(s): Nirogacestat Hydrobromide
  • Strength: EQ 50MG BASE
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Springworks
  • Approval Date: 27 November 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for adult patients with progressing desmoid tumors who require systemic treatment.
  • Approved Label:  27 November 2023 (PDF)
ALVAIZ
  • Active Ingredient(s): Eltrombopag Choline
  • Strength: EQ 9MG BASE, EQ 18MG BASE, EQ 36MG BASE, EQ 54MG BASE
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Springworks
  • Approval Date: 29 November 2023
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated:
    • for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
    • for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferonbased therapy.
    • for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
    Limitations of Use:
    • ALVAIZ is not indicated for the treatment of patients with myelodysplastic syndrome (MDS).
    • Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
  • Approved Label:  29 November 2023 (PDF)