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.
For fibrodysplasia ossificans progressiva (FOP). Sold as Sohonos. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Palovarotene (sold as Sohonos), first approved Aug 16, 2023, with 1 new use approved and 1 published complete response letter.
First approved: Aug 16, 2023
Applications: 1
New uses approved: 1
Complete response letters: 1
Medicare spending, 2025: $3.8M
Orphan exclusivity until: Aug 16, 2030
First approved in Japan: Feb 19, 2026
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 30 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Sohonos, new ingredientDrugs with a new active ingredient indicated for the treatment of fibrodysplasia ossificans progressiva. · IPSEN Co., Ltd. · Feb 19, 2026
PalovarotenePostmarketing Requirements Under 505(0)(3)
Approved
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
Ipsen