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.
Sold as Avodart. Every FDA application for this active ingredient: 1 branded and 19 generic.
As of Nov 14, 2026, FDA lists 20 applications for Dutasteride (sold as Avodart), first approved Nov 20, 2001, with 4 new uses approved and 0 published complete response letters.
First approved: Nov 20, 2001
Applications: 20
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $35.3M
First approved in Japan: Jul 7, 2009
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Dutasteride
Part D
$31.6M
+0%
272,938
Avodart
Part D
$3.7M
-46%
351
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
DUTASTERIDE 0.5 MG CAPSULE: $0.155 per unitGeneric · -12% in a year
Approvals in Japan (PMDA)
First approved in Japan 92 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Zagallo, new approvalA drug with a new indication and a new dosage in an additional dosage form, and a drug with a new indication and a new dosage, indicated for the treatment… · GlaxoSmithKline K.K. · Sep 28, 2015 · Review report
Avolve, new ingredientA drug with a new active ingredient indicated for the treatment of benign prostatic hyperplasia. · GlaxoSmithKline K.K. · Jul 7, 2009
Clinical Trials
13 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
Hikma
Apotex
Zydus Lifesciences
Strides Pharma