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.
Treats metastatic ovarian cancer after disease progression on or after initial or…. Sold as Hycamtin, Topotecan Hydrochloride, Topotecan. Every FDA application for this active ingredient: 5 branded and 13 generic.
As of Nov 15, 2026, FDA lists 18 applications for Topotecan Hydrochloride (sold as Hycamtin, Topotecan Hydrochloride, Topotecan), first approved May 28, 1996, with 4 new uses approved and 0 published complete response letters.
First approved: May 28, 1996
Applications: 18
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $2.2M
First approved in the EU: Nov 12, 1996
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
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
Sandoz
Fresenius Kabi USA
Accord Hlthcare
Sun Pharm Inds Ltd