Original New Drug Application Approvals by US FDA (16 - 30 November 2022)

05 Dec 2022
Original New Drug Application Approvals by US FDA (16 - 30 November 2022)
New drug applications approved by US FDA as of 16 - 30 November 2022 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.

TZIELD
  • Active Ingredient(s): Teplizumab-mzwv
  • Strength: 2MG/2ML(1MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Provention Bio Inc
  • Approval Date: 17 November 2022
  • Submission Classification: NA
  • Indication(s): Indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. 
  • Approved Label: 17 November (PDF)
SEZABY
  • Active Ingredient(s): Phenobarbital Sodium
  • Strength: 100MG/VIAL
  • Dosage Form(s) / Route(s): Powder; Intravenous
  • Company: SPARC
  • Approval Date: 17 November 2022
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): NA
  • Approved Label:NA
DOCETAXEL
  • Active Ingredient(s): Docetaxel
  • Strength: 10MG/ML;20MG/2ML;80MG/8ML;160MG/16ML
  • Dosage Form(s) / Route(s): Injectable;Injection
  • Company: Meridian Laboratories Inc
  • Approval Date: 22 November 2022
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC
    • Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
    • Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
    • Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction
    • Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN.
  • Approved Label: 22 November (PDF)
JYLAMVO
  • Active Ingredient(s): Methotrexate
  • Strength: 2MG/MLl
  • Dosage Form(s) / Route(s): Solution;Oral;Suspension;oral
  • Company: Therakind Limited
  • Approval Date: 29 November 2022
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the:
    • Treatment of adults with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen
    • Treatment of adults with mycosis fungoides
    • Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen
    • Treatment of adults with rheumatoid arthritis
    • Treatment of adults with severe psoriasis
  • Approved Label: 29 November (PDF)