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