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Cerdelga Approval History

FDA Approved: Yes (First approved August 19, 2014)
Brand name: Cerdelga
Generic name: eliglustat
Dosage form: Capsules
Company: Genzyme Corporation
Treatment for: Gaucher Disease

Cerdelga (eliglustat) is a glucosylceramide synthase inhibitor indicated for the long- term treatment of adult patients with Gaucher disease type 1.

Development History and FDA Approval Process for Cerdelga

DateArticle
Aug 19, 2014Approval FDA Approves Cerdelga (eliglustat) for Type 1 Gaucher Disease
Dec 11, 2013FDA Grants Priority Review for Genzyme’s Cerdelga (eliglustat), an Investigational Oral Therapy for Gaucher Disease

Further information

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