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

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

CYCLOPHOSPHAMIDE
  • Active Ingredient(s): Cyclophosphamide
  • Strength: 500MG/ML (500MG/ML); 1GM/2ML (500MG/ML); 2GM/4ML (500MG/ML)
  • Dosage Form(s) / Route(s): Solution;intravenous
  • Company: Dr Reddys Labs Ltd
  • Approval Date: 07 June 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for treatment of adult and pediatric patients with:

    Malignant Diseases: malignant lymphomas: Hodgkin’s disease, 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:
    The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.
  • Approved Label:  07 June (PDF)
SUFLAVE
  • Active Ingredient(s): Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Sodium Chloride; Sodium Sulfate
  • Strength: 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT
  • Dosage Form(s) / Route(s): For Solution;oral
  • Company: Braintree Labs
  • Approval Date: 15 June 2023
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for cleansing of the colon in preparation for colonoscopy in adults
  • Approved Label:  15 June (PDF)
COLUMVI
  • Active Ingredient(s): Glofitamab-gxbm
  • Strength: 2.5MG/2.5ML(1MG/ML); 10MG/10ML(1MG/ML)
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Genentech Inc
  • Approval Date: 15 June 2023
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

    This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Approved Label:  15 June (PDF)