Original New Drug Application Approvals by US FDA (01-15 January 2024)

New drug applications approved by US FDA as of  01-15 January 2024 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.

ZELSUVMI

• Active Ingredient(s): Berdazimer Sodium
• Strength: EQ 10.3% Base
• Dosage Form(s) / Route(s): Gel;topical
• Company: LNHC
• Approval Date: 05 January 2024
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Not Available
• Approved Label: Not Available