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Elaprase Approval History

  • FDA approved: Yes (First approved July 24th, 2006)
  • Brand name: Elaprase
  • Generic name: idursulfase
  • Dosage form: Injection
  • Company: Shire plc
  • Treatment for: Mucopolysaccharidosis Type II

Elaprase (idursulfase) is a purified form of the human lysosomal enzyme iduronate-2-sulfatase produced by recombinant DNA technology. Elaprase is indicated for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II).

Development History and FDA Approval Process for Elaprase

Jul 24, 2006Approval Elaprase Shire plc - Treatment for Hunter Syndrome
May 17, 2006Shire Provides Update on U.S. Marketing Application of Elaprase
Nov 24, 2005Shire Files Elaprase (idursulfase) With the FDA for the Treatment of Hunter Syndrome

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