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 metastatic carcinoma of the colon or rectum. Sold as Camptosar, Onivyde. Every FDA application for this active ingredient: 2 branded and 27 generic.
As of Nov 15, 2026, FDA lists 29 applications for Irinotecan Hydrochloride (sold as Camptosar, Onivyde), first approved Jun 14, 1996, with 5 new uses approved and 0 published complete response letters.
First approved: Jun 14, 1996
Applications: 29
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $1.4M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Onivyde, new approvalA drug with a new indication in a new dosage form for the treatment of unresectable pancreatic cancer that has progressed after cancer chemotherapy. · Nihon Servier Co., Ltd. · Mar 25, 2020
CamptoDrugs with a new additional indication and a new dosage for the treatment of unresectable pancreatic cancer. · Yakult Honsha Co., Ltd. · Dec 20, 2013
TopotecinDrugs with a new additional indication and a new dosage for the treatment of unresectable pancreatic cancer. · Daiichi Sankyo Company, Limited · Dec 20, 2013
CamptoDrugs with a new additional indication and a new dosage for the treatment of pediatric malignant solid tumor. · Hospira Japan Co., Ltd. · Mar 25, 2013
Clinical Trials
595 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
Fresenius Kabi USA
Sandoz
Accord Hlthcare
Hikma
Ipsen
Eugia Pharma