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)