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