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