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

18 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 Label12 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 Label14 May 2021 (PDF)
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