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

18 Nov 2024
Original New Drug Application Approvals by US FDA (1-15 November 2024)
New drug applications approved by US FDA as of 1-15 November 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.

EMROSI
  • Active Ingredient(s): Minocycline Hydrochloride
  • Strength: 40MG
  • Dosage Form(s) / Route(s): Capsule, Extended Release;oral
  • Company: Dr Reddys
  • Approval Date: 1 November 2024
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults.
    • Limitations of Use
    This formulation of minocycline has not been evaluated in the treatment or prevention of infections. To reduce the development of drug-resistant bacteria and to maintain the effectiveness of other antibacterial drugs, use EMROSI only as indicated.
  • Approved Label:  1 November 2024 (PDF)
DANZITEN
  • Active Ingredient(s): Nilotinib Tartrate
  • Strength: 71MG; 95MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Azurity Pharmaceuticals Inc
  • Approval Date: 7 November 2024
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
    • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
  • Approved Label:  7 November 2024 (PDF)
REVUFORJ
  • Active Ingredient(s): Revumenib Citrate
  • Strength: EQ 25MG BASE; EQ 110MG BASE; EQ 160MG BASE
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Syndax
  • Approval Date: 15 November 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
  • Approved Label:  15 November 2024 (PDF)