Original New Drug Application Approvals by US FDA (1-15 April 2026)

New drug applications approved by US FDA as of 1-15 April 2026 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.

FOUNDAYO

• Active Ingredient(s): Orforglipron Calcium
• Strength: EQ 0.8MG BASE; EQ 2.5MG BASE; EQ 5.5MG BASE; EQ 9MG BASE; EQ 14.5MG BASE; EQ 17.2MG BASE
• Dosage Form(s) / Route(s): Tablet;oral
• Company: Eli Lilly And Co
• Approval Date: 1 April 2026
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
  Limitations of Use
  Concomitant use with another GLP-1 receptor agonist is not recommended.
• Approved Label:  1 April 2026 (PDF)