Original New Drug Application Approvals by US FDA (01-15 September 2023)

15 Sep 2023
Original New Drug Application Approvals by US FDA (01-15 September 2023)
New drug applications approved by US FDA as of 01-15 September 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.

XALKORI
  • Active Ingredient(s): Crizotinib
  • Strength: 20MG, 50MG, 150MG
  • Dosage Form(s) / Route(s): Pellets;oral
  • Company: Pf Prism Cv
  • Approval Date: 07 September 2023
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of
    • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.
    • pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.
      Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
    • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.
  • Approved Label:  07 September (PDF)
APHEXDA
  • Active Ingredient(s): Motixafortide
  • Strength: 62MG
  • Dosage Form(s) / Route(s): Injectable;subcutaneous Lyophilized Power
  • Company: Biolinerx, Ltd.
  • Approval Date: 08 September 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
  • Approved Label:  08 September 2023 (PDF)
CYCLOPHOSPHAMIDE
  • Active Ingredient(s): Cyclophosphamide
  • Strength: 500MG/5ML(100MG/ML, 1000MG/10ML(100MG/ML, 2000MG/20ML(100MG/ML
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Sandoz Inc
  • Approval Date: 12 September 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for treatment of adult patients with:

    Malignant Diseases: malignant lymphomas: Hodgkin’s lymphoma, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma.

    Limitations of Use
    This cyclophosphamide product is not indicated for use in pediatric patients due to the alcohol and propylene glycol content in this product. If treatment with cyclophosphamide is indicated in a pediatric patient, use a different cyclophosphamide product.
  • Approved Label:  12 September 2023 (PDF)
OJJAARA
  • Active Ingredient(s): Momelotinib Dihydrochloride
  • Strength: 100MG, 150MG, 200MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Sandoz Inc
  • Approval Date: 15 September 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [postpolycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.
  • Approved Label:  15 September 2023 (PDF)