Original New Drug Application Approvals by US FDA (16 - 30 November 2020)

02 Dec 2020
Original New Drug Application Approvals by US FDA (16 - 30 November 2020)
New drug applications approved by US FDA as of 16 - 30 November 2020 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.

ZOKINVY
  • Active Ingredient(s): Ionafarnib
  • Strength: 50 mg; 75 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Eiger Biopharmaceuticals, Inc.
  • Approval Date: 20 November 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in patients 12 months of age and older with a body surface area of 0.39 m2 and above:
    • To reduce risk of mortality in Hutchinson-Gilford Progeria Syndrome
    • For treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMNA mutation with progerin-like protein accumulation or Homozygous or compound heterozygous ZMPSTE24 mutations
  • Approved Label: 20 November 2020 (PDF)

OXLUMO
  • Active Ingredient(s): Lumasiran
  • Strength: 94.5 mg/0.5 mL
  • Dosage Form(s) / Route(s): Solution; subcutaneous
  • Company: Alnylam Pharms, Inc.
  • Approval Date: 23 November 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Not available
  • Approved Label: Not available

XOFLUZA
  • Active Ingredient(s): Baloxavir marboxik
  • Strength: 20 mg; 40 mg
  • Dosage Form(s) / Route(s): Suspension; oral
  • Company: Genentech, Inc.
  • Approval Date: 23 November 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for:
    • Treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are: otherwise healthy, or at high risk of developing influenza-related complications.
    • Post-exposure prophylaxis of influenza in patients 12 years of age and older following contact with an individual who has influenza.
  • Approved Label: 23 November 2020 (PDF)

DANYELZA
  • Active Ingredient(s): Naxitamab-gqgk
  • Strength: 40 mg; 10 mL
  • Dosage Form(s) / Route(s): Solution; intravenous
  • Company: Y-mAbs Therapeutics, Inc.
  • Approval Date: 25 November 2020
  • Submission Classification: Not available
  • Indication(s): Indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
  • Approved Label: 25 November 2020 (PDF)

IMCIVREE
  • Active Ingredient(s): Setmelanotide
  • Strength: 10 mg/mL
  • Dosage Form(s) / Route(s): Solution; subcutaneous
  • Company: Rhythm Pharmaceuticals, Inc.
  • Approval Date: 25 November 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for chronic weight management in adult and pediatric patients 6 years if age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). 
  • Approved Label: 25 November 2020 (PDF)

THYQUIDITY
  • Active Ingredient(s): Levothyroxine sodium
  • Strength: 100 mcg/5 mL
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Reguliance, LLC
  • Approval Date: 30 November 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available