Elaprase FDA Approval History
FDA Approved: Yes (First approved July 24, 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 timeline for Elaprase
| Date | Article |
|---|---|
| Jul 24, 2006 | Approval 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 |
Further information
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