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