Original New Drug Application Approvals by US FDA (16-31 March 2023)

31 Mar 2023
Original New Drug Application Approvals by US FDA (16-31 March 2023)
New drug applications approved by US FDA as of 16-31 March 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.

MEKINIST
  • Active Ingredient(s): Trametinib Dimethyl Sulfoxide; Trametinib
  • Strength: EQ 0.05MG BASE/ML; 2MG; 4.7MG
  • Dosage Form(s) / Route(s): Solution;oral / Tablet;oral / Solution;oral
  • Company: Novartis
  • Approval Date: 16 March 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDAapproved test.

    MEKINIST is indicated, in combination with dabrafenib, for:
    • the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
    • the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
    • the treatment of patients with metastatic non-small cell lung cancer(NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
    • the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.
    • the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
    • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

    Limitations of Use: MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.
  • Approved Label:  16 March (PDF)
TAFINLAR
  • Active Ingredient(s): Dabrafenib Mesylate
  • Strength: EQ 10MG BASE; 75MG; 10MG
  • Dosage Form(s) / Route(s): Tablet, For Suspension;oral / Capsule;oral / Tablet; Oral Suspension
  • Company: Novartis
  • Approval Date: 16 March 2023
  • Submission Classification: NA
  • Indication(s): Indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

    TAFINLAR is indicated, in combination with trametinib, for:
    • the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
    • the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
    • the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
    • the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.
    • the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
    • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy

    Limitations of Use: TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. TAFINLAR is not indicated for treatment of patients with wildtype BRAF solid tumors.
  • Approved Label:  16 March (PDF)
REZZAYO
  • Active Ingredient(s): Rezafungin Acetate
  • Strength: EQ 200MG BASE/VIAL
  • Dosage Form(s) / Route(s): Powder;intravenous
  • Company: Cidara Theraps
  • Approval Date: 22 March 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data for REZZAYO.

    Limitations of Use:
    REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
  • Approved Label:  22 March (PDF)
ZYNYZ
  • Active Ingredient(s): Retifanlimab-dlwr
  • Strength: 500MG/20ML(25MG/ML)
  • Dosage Form(s) / Route(s): Injectable;intravenous
  • Company: Incyte Corp
  • Approval Date: 22 March 2023
  • Submission Classification: NA
  • Indication(s): Indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

    This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • Approved Label:  22 March (PDF)
JOENJA
  • Active Ingredient(s): Leniolisib Phosphate
  • Strength: 70MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Pharming Technologies Bv
  • Approval Date: 24 March 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
  • Approved Label:  24 March (PDF)