Original-New-Drug-Application-Approvals-by-US-FDA--1-15-December-2025

New drug applications approved by US FDA as of 1-15 December 2025 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.

CARDAMYST

• Active Ingredient(s): Etripamil
• Strength: 70MG
• Dosage Form(s) / Route(s): Spray;nasal
• Company: Milestone Pharms Usa
• Approval Date: 12 December 2025
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
• Approved Label:  12 December 2025 (PDF)

NUZOLVENCE

• Active Ingredient(s): Zoliflodacin
• Strength: 3GM/PACKET
• Dosage Form(s) / Route(s): Suspension;oral
• Company: Entasis Therap
• Approval Date: 12 December 2025
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg.
  Usage to Reduce Development of Drug-Resistant Bacteria
  To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
• Approved Label:  12 December 2025 (PDF)