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.
Prevents skeletal-related events. Sold as Bildyos, Bilprevda. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Denosumab-Nxxp (sold as Bildyos, Bilprevda), first approved Oct 29, 2025, with 0 new uses approved and 0 published complete response letters.
First approved: Oct 29, 2025
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $195K
First approved in the EU: May 26, 2010
First approved in Japan: Jan 18, 2012
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Bildyos
Part D
$195K
New
224
Bilprevda
Part D
$0K
New
0
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
BILDYOS 60 MG/ML SYRINGE: $813.05 per MLBrand · new this year
FDA Drug Safety Communications
One communication since 2020 that name this drug; see all communications
First approved in Japan 165 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
ProliaA drug with a new additional indication and a new dosage indicated for inhibiting progression of bone erosion associated with rheumatoid arthritis. · Daiichi Sankyo Company, Limited · Jul 3, 2017
RanmarkA drug with a new additional indication and a new dosage for the treatment of giant cell tumor of bone. · Daiichi Sankyo Company, Limited · May 23, 2014
Pralia, new approvalA drug with a new indication and a new dosage for the treatment of osteoporosis. · Daiichi Sankyo Company, Limited · Mar 25, 2013
Ranmark, new ingredientA drug with a new active ingredient indicated for the treatment of bone lesions due to multiple myeloma and bone lesions due to bone metastasis of solid tumor. · Daiichi Sankyo Company, Limited · Jan 18, 2012
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
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
