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

20 Feb 2023
New drug applications approved by US FDA as of 01-15 February 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.

  • Active Ingredient(s): Atorvastatin Calcium
  • Strength: 20MG/5ML
  • Dosage Form(s) / Route(s): Suspension;oral
  • Company: Cmp Dev Llc
  • Approval Date: 01 February 2023
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated:
    • To reduce the risk of:
      • Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
      • MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
      • Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure (CHF), and angina in adults with clinically evident CHD.
    • As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in:
      • Adults with primary hyperlipidemia.
      • Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
    • As an adjunct to other LDL-C lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia.
    • As an adjunct to diet for the treatment of adults with:
      • Primary dysbetalipoproteinemia.
      • Hypertriglyceridemia.
  • Approved Label:  01 February (PDF)
  • Active Ingredient(s): Daprodustat
  • Strength: 1MG; 2MG; 4MG; 6MG; 8MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Glaxosmithkline
  • Approval Date: 01 February 2023
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months.
    Limitations of Use
    Not shown to improve quality of life, fatigue, or patient well-being.
    Not indicated for use:
    • As a substitute for transfusion in patients requiring immediate correction of anemia.
    • In patients not on dialysis.
  • Approved Label:  01 February (PDF)
  • Active Ingredient(s): Fentanyl Citrate
  • Strength: 50MCG
  • Dosage Form(s) / Route(s): Injectable;injection
  • Company: Exela Pharma Science
  • Approval Date: 08 February 2023
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adult and pediatric patients ages 2 years and older for:
    • use as an opioid analgesic supplement in general anesthesia.
    • administration with a neuroleptic for the induction of anesthesia and as an adjunct in the maintenance of general anesthesia.
    • use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.
  • Approved Label:  08 February (PDF)
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