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Ruconest Approval History

  • FDA approved: Yes (First approved July 16th, 2014)
  • Brand name: Ruconest
  • Generic name: C1 esterase inhibitor (recombinant)
  • Previous name: Rhucin
  • Company: Pharming Group NV
  • Treatment for: Hereditary Angioedema

Ruconest is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

Development History and FDA Approval Process for Ruconest

Jul 17, 2014Approval FDA Approves Ruconest for Hereditary Angioedema
Feb 28, 2011Santarus and Pharming Announce Receipt of FDA Refusal to File Letter for Rhucin Biologics License Application
Dec 28, 2010Pharming And Santarus Announce Submission Of Rhucin Biologics License Application to FDA
Jan 29, 2008Pharming Provides Update on Rhucin

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