Original New Drug Application Approvals by US FDA (01 - 15 June 2020)

16 Jun 2020
Original New Drug Application Approvals by US FDA (01 - 15 June 2020)
New drug applications approved by US FDA as of 01 - 15 June 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.

NYVEPRIA
  • Active Ingredient(s): Pegfilgrastim-apgf
  • Strength: 6 mg/0.6 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Hospira, Inc.
  • Approval Date: 10 June 2020
  • Submission Classification: Not available
  • Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • Approved Label: 10 June 2020 (PDF)

SEMGLEE
  • Active Ingredient(s): Insulin glargine
  • Strength: 100 units/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Mylan Pharms, Inc.
  • Approval Date: 11 June 2020
  • Submission Classification: Not available
  • Indication(s): Indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
  • Approved Label: 11 June 2020 (PDF)

UPLIZNA 
  • Active Ingredient(s): Inebilizumab
  • Strength: 100 mg/10 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Viela Bio
  • Approval Date: 11 June 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
  • Approved Label: 11 June 2020 (PDF)

TIVICAY PD
  • Active Ingredient(s): Dolutegravir
  • Strength: 5 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Viiv Healthcare
  • Approval Date: 12 June 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): 
    • Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least 4 weeks and weighing at least 3 kg.
    • Indicated in combination with rilpivirine 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 for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.
  • Approved Label: 12 June 2020 (PDF)

ZEPZELCA
  • Active Ingredient(s): Lurbinectedin
  • Strength: 4 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pharma Mar USA, Inc.
  • Approval Date: 15 June 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
  • Approved Label: 15 June 2020 (PDF)

LYUMJEV
  • Active Ingredient(s): Insulin lispro-aabc
  • Strength: 100 units/mL (U-100); 200 units/mL (U-200)
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Eli Lilly and Co.
  • Approval Date: 15 June 2020
  • Submission Classification: Not available
  • Indication(s): Indicated to improve glycemic control in adults with diabetes mellitus.
  • Approved Label: 15 June 2020 (PDF)