Original New Drug Application Approvals by US FDA (16 - 31 December 2020)

05 Jan 2021
New drug applications approved by US FDA as of 16 - 31 December 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.

MARGENZA
  • Active Ingredient(s): Margetuximab-CMKB
  • Strength: 250mg/10mL (25mg/mL)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Macrogenics, Inc.
  • Approval Date: 16 Dec 2020
  • Submission Classification: Not Available
  • Indication(s): Not Available
  • Approved Label: Not Available

RIABNI
  • Active Ingredient(s): Rituximab-ARRX
  • Strength: 100mg/10mL (10mg/mL)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Amgen, Inc.
  • Approval Date: 17 Dec 2020
  • Submission Classification: Not Available
  • Indication(s): Indicated for:
    • Adult patients with non-Hodgkin’s Lymphoma
    • Adult patients with Chronic Lymphocytic Leukemia (CLL)
    • Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids 
  • Approved Label: 17 Dec 2020 (PDF) 

ORGOVYX
  • Active Ingredient(s): Relugolix
  • Strength: 120 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Myovant Sciences
  • Approval Date: 18 Dec 2020 
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with advanced prostate cancer
  • Approved Label: 18 Dec 2020 (PDF)

GEMTESA
  • Active Ingredient(s): Vibegron
  • Strength: 75 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Urovant Sciences GMBH
  • Approval Date: 23 Dec 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults
  • Approved Label: 23 Dec 2020 (PDF)
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