Original New Drug Application Approvals by US FDA (16-30 June 2023)
01 Jul 2023
New drug applications approved by US FDA as of 16-30 June 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.
LODOCO
LODOCO
- Active Ingredient(s): Colchicine
- Strength: 0.5 mg
- Dosage Form(s) / Route(s): Tablet; Oral
- Company: Agephapharmafz Llc
- Approval Date: 16 June 2023
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.
- Approved Label: 16 June (PDF)
- Active Ingredient(s): Efgartigimod Alfa And Hyaluronidase-qvfc
- Strength: 1008mg;11200units Per 5.6ml
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Argenx Bv
- Approval Date: 20 June 2023
- Submission Classification: NA
- Indication(s): Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
- Approved Label: 20 June (PDF)
- Active Ingredient(s): Ritlecitinib
- Strength: 50MG
- Dosage Form(s) / Route(s): Capsule;oral
- Company: Pfizer Inc
- Approval Date: 23 June 2023
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants - Approved Label: 23 June (PDF)
- Active Ingredient(s): Rozanolixizumab-noli
- Strength: 280MG/2ML(140MG/ML)
- Dosage Form(s) / Route(s): Injectable;subcutaneous
- Company: UCB INC
- Approval Date: 26 June 2023
- Submission Classification: NA
- Indication(s): Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive.
- Approved Label: 26 June (PDF)
- Active Ingredient(s): Cyclophosphamide
- Strength: 500MG/2.5ML (200MG/ML); 1GM/5ML (200MG/ML)
- Dosage Form(s) / Route(s): Solution;intravenous
- Company: Nevakar Injectables
- Approval Date: 27 June 2023
- Submission Classification: NA
- Indication(s): Indicated for the treatment of:
- Malignant lymphomas (Stages 3 and 4 of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma.
- Multiple myeloma
- Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration).
- Mycosis fungoides (advanced disease)
- Neuroblastoma (disseminated disease)
- Adenocarcinoma of the ovary
- Retinoblastoma
- Carcinoma of the breast
- Approved Label: 27 June (PDF)
- Active Ingredient(s): Somatrogon-ghla
- Strength: 24MG; 60MG
- Dosage Form(s) / Route(s): Injectable;injection
- Company: Pfizer Ireland Pharmaceuticals
- Approval Date: 27 June 2023
- Submission Classification: NA
- Indication(s): Indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
- Approved Label: 27 June (PDF)