Original New Drug Application Approvals by US FDA (01 - 15 October 2022)

New drug applications approved by US FDA as of 01 - 15 October 2022 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.

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

• Active Ingredient(s): Norepinephrine Bitartrate
• Strength: EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML); EQ 8MG BASE/250ML (EQ 32MCG BASE/ML); EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)
• Dosage Form(s) / Route(s): Solution; Intravenous
• Company: Nevakar Injectables, Inc.
• Approval Date: 06 October 2022
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): NA
• Approved Label:NA

FUROSCIX

• Active Ingredient(s): Furosemide
• Strength: 80MG/10ML
• Dosage Form(s) / Route(s): Injectable;Injection
• Company: Scpharmaceuticals Inc
• Approval Date: 07 October 2022
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of congestion due to fluid overload in adults with NYHA Class II/III chronic heart failure.
• Approved Label:  07 October (PDF)

CEFAZOLIN SODIUM

• Active Ingredient(s): Cefazolin Sodium
• Strength: EQ 2GM/VIAL; EQ 3GM/VIAL
• Dosage Form(s) / Route(s): Powder; Intravenous
• Company: Hikma
• Approval Date: 07 October 2022
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for:
  • Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved:
    • Respiratory tract infections
    • Urinary tract infections
    • Skin and skin structure infections
    • Biliary tract infections
    • Bone and joint infections
    • Genital infections
    • Septicemia
    • Endocarditis
  • Perioperative prophylaxis in adult patients
• Approved Label:  07 October (PDF)