Original New Drug Application Approvals by US FDA (16 - 31 January 2021)

02 Feb 2021
Original New Drug Application Approvals by US FDA (16 - 31 January 2021)
New drug applications approved by US FDA as of 16-31 January 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.

VERQUVO
  • Active Ingredient(s): Vericiguat
  • Strength: 2.5MG; 5MG; 10MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Merck Sharp Dohme
  • Approval Date: 19 Jan 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.
  • Approved Label: 19 Jan 2021 (PDF)
VOCABRIA
  • Active Ingredient(s): Cabotegravir
  • Strength: 30MG
  • Dosage Form(s) / Route(s): Tablet; Film Coated
  • Company: ViiV Healthcare
  • Approval Date: 21 Jan 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s):   Not Available
  • Approved Label: Not Available
CABENUVA
  • Active Ingredient(s): Cabotegravir; Rilpivirine
  • Strength: 400MG/2ML; 600MG/2ML; 600MG/3ML; 900MG/3ML
  • Dosage Form(s) / Route(s): Suspension; Extended Release; Intramuscular
  • Company: ViiV Healthcare
  • Approval Date: 21 Jan 2021
  • Submission Classification: Type 1 - New Molecular Entity; Type 4 - New Combination
  • Indication(s):  indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
  • Approved Label: 21 Jan 2021 (PDF)
LUPKYNIS
  • Active Ingredient(s): Voclosporin
  • Strength: 7.9MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Aurinia Pharmaceuticals, Inc.
  • Approval Date: 22 Jan 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s):   indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN).
  • Approved Label: 22 Jan 2021 (PDF)