Original New Drug Application Approvals by US FDA (16-30 September 2021)

04 Oct 2021
New drug applications approved by US FDA as of 16 - 30 September 2021 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.

BYOOVIZ
  • Active Ingredient(s): Ranibizumab-nuna
  • Strength: 0.5MG(10MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Samsung Bioepis Co Ltd
  • Approval Date: 17 September 2021
  • Submission Classification: Not available
  • Indication(s): indicated for the treatment of patients with:
    • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
    • Macular Edema Following Retinal Vein Occlusion (RVO)
    • Myopic Choroidal Neovascularization (mCNV)
  • Approved Label: 17 September 2021 (PDF)
TIVDAK
  • Active Ingredient(s): Tisotumab Vedotin-tftv
  • Strength: 40MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Seagen
  • Approval Date: 20 September 2021
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  • Approved Label: 20 September 2021 (PDF)
OPZELURA
  • Active Ingredient(s): Ruxolitinib
  • Strength: 1%
  • Dosage Form(s) / Route(s): Cream; Topical
  • Company: Incyte Corp
  • Approval Date: 21 September 2021
  • Submission Classification: Not available
  • Indication(s): Not available
  • Approved Label: Not available
QULIPTA
  • Active Ingredient(s): Atogepant
  • Strength: 10MG; 30MG; 60MG
  • Dosage Form(s) / Route(s):Tablet; Oral
  • Company: Abbvie Inc
  • Approval Date: 28 September 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the preventive treatment of episodic migraine in adults.
  • Approved Label: 28 September 2021 (PDF)
LIVMARLI
  • Active Ingredient(s): Maralixibat
  • Strength: 9.5MG
  • Dosage Form(s) / Route(s): Solution; Oral
  • Company: Mirum Pharma Inc
  • Approval Date: 29 September 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.
  • Approved Label: 29 September 2021 (PDF)
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