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VPRIV FDA Approval History

FDA Approved: Yes (First approved February 26, 2010)
Brand name: VPRIV
Generic name: velaglucerase alfa
Dosage form: for Injection
Company: Shire plc
Treatment for: Gaucher Disease

VPRIV (velaglucerase alfa) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy for pediatric and adult patients with Type 1 Gaucher disease.

Development timeline for VPRIV

Feb 26, 2010Approval FDA Approves VPRIV to Treat Gaucher Disease
Nov  4, 2009FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher Disease
Sep  2, 2009Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials
Jul  7, 2009Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease

Further information

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