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Ravicti Approval History

FDA Approved: Yes (First approved February 1, 2013)
Brand name: Ravicti
Generic name: glycerol phenylbutyrate
Dosage form: Oral Liquid
Company: Hyperion Therapeutics
Treatment for: Urea Cycle Disorders

Ravicti (glycerol phenylbutyrate) is a nitrogen-binding agent for the chronic management of patients with urea cycle disorders.

Development History and FDA Approval Process for Ravicti

DateArticle
Dec 27, 2018Approval Horizon Pharma plc Announces FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns
May  1, 2017Approval Horizon Pharma plc Announces FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to People with Urea Cycle Disorders Two Months of Age and Older
Feb  1, 2013Approval FDA Approves Ravicti for the Chronic Management of Some Urea Cycle Disorders

Further information

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