Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Manages urea cycle disorders involving deficiencies of carbamoyl phosphate synthetase…. Sold as Buphenyl, Olpruva, Pheburane. Every FDA application for this active ingredient: 4 branded and 6 generic.
As of Nov 15, 2026, FDA lists 10 applications for Sodium Phenylbutyrate (sold as Buphenyl, Olpruva, Pheburane), first approved Apr 30, 1996, with 1 new use approved and 1 published complete response letter.
First approved: Apr 30, 1996
Applications: 10
New uses approved: 1
Complete response letters: 1
Medicare spending, 2025: $5.3M
First approved in the EU: Dec 7, 1999
First approved in Japan: Sep 28, 2012
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 197 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Buphenyl, new ingredientDrugs with a new active ingredient indicated for the treatment of urea cycle disorder. · CMIC Holdings, Co., Ltd. · Sep 28, 2012
Clinical Trials
9 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
