Original New Drug Application Approvals by US FDA (01 - 15 May 2021)

New drug applications approved by US FDA as of 01-15 May 2021 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.

ZYNRELEF

• Active Ingredient(s): Bupivacaine and Meloxicam
• Strength: 60MG/1.8MG; 200MG/6MG; 300MG/9MG; 400MG/12MG
• Dosage Form(s) / Route(s): Solution; Injection
• Company: Heron Therapeutics, Inc.
• Approval Date: 12 May 2021
• Submission Classification: Type 4 - New Combination
• Indication(s): Indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. 
• Approved Label: 12 May 2021 (PDF)

EMPAVELI

• Active Ingredient(s): Pegcetacoplan
• Strength: 1080MG/20ML(54MG/ML)
• Dosage Form(s) / Route(s): Injectable; Injection
• Company: Apellis Pharmaceuticals Inc
• Approval Date: 14 May 2021
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
• Approved Label: 14 May 2021 (PDF)