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

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)