Most Read Articles
02 Jun 2020
New drug applications approved by US FDA as of 16 - 31 May 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. 
Pearl Toh, Yesterday
While children with inflammatory bowel disease (IBD) see their conditions improve with biologic therapy, those with ulcerative colitis (UC) tend to have residual disease activity even after clinical remission, according to two separate studies presented at the 2021 Crohn’s and Colitis Congress.

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

02 Dec 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 Label20 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 Label23 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 Label25 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 Label25 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
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Most Read Articles
02 Jun 2020
New drug applications approved by US FDA as of 16 - 31 May 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. 
Pearl Toh, Yesterday
While children with inflammatory bowel disease (IBD) see their conditions improve with biologic therapy, those with ulcerative colitis (UC) tend to have residual disease activity even after clinical remission, according to two separate studies presented at the 2021 Crohn’s and Colitis Congress.