Original New Drug Application Approvals by US FDA (1-15 May 2024)

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

MYHIBBIN

• Active Ingredient(s): Mycophenolate Mofetil
• Strength: 200MG/ML
• Dosage Form(s) / Route(s): Suspension;oral
• Company: Azurity
• Approval Date: 1 May 2024
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
• Approved Label:  1 May 2024 (PDF)