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

01 Jul 2021
Original New Drug Application Approvals by US FDA (16 - 30 June 2021)
New drug applications approved by US FDA as of 16-30 June 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.

MICAFUNGIN
  • Active Ingredient(s): Micafungin Sodium
  • Strength: EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL
  • Dosage Form(s) / Route(s): Powder; Intravenous
  • Company: Par Sterile Products
  • Approval Date: 16 June 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available
DAPTOMYCIN
  • Active Ingredient(s): Daptomycin
  • Strength: 350MG/VIAL; 500MG/VIAL
  • Dosage Form(s) / Route(s): Powder; Intravenous, Subcutaneous
  • Company: Hospira Inc
  • Approval Date: 21 June 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): indicated for the treatment of:
    • Complicated skin and skin structure infections (cSSSI) in adult patients and,
    • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis
  • Approved Label: 21 June 2021 (PDF)
PRADAXA
  • Active Ingredient(s): Dabigatran
  • Strength: 20MG, 30MG, 40MG, 50MG, 110MG, 150MG
  • Dosage Form(s) / Route(s): Pellets; Oral
  • Company: Boehringer Ingelheim
  • Approval Date: 21 June 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): indicated:
    • For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days
    • To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated
  • Approved Label: 21 June 2021 (PDF)
VERKAZIA
  • Active Ingredient(s): Cyclosporine
  • Strength: 0.1%
  • Dosage Form(s) / Route(s): Emulsion; Ophthalmic
  • Company: Santen
  • Approval Date: 23 June 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s):  Indicated for the treatment of vernal keratoconjunctivitis in children and adults.
  • Approved Label: 23 June 2021 (PDF)