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Treats postmenopausal women with hormone receptor positive early breast cancer. Sold as Femara. Every FDA application for this active ingredient: 1 branded and 22 generic.
As of Nov 14, 2026, FDA lists 23 applications for Letrozole (sold as Femara), first approved Jul 25, 1997, with 8 new uses approved and 0 published complete response letters.
First approved: Jul 25, 1997
Applications: 23
New uses approved: 8
Complete response letters: 0
Medicare spending, 2025: $22.7M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Letrozole
Part D
$21.4M
+12%
222,193
Femara
Part D
$1.3M
-2%
198
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
LETROZOLE 2.5 MG TABLET: $0.150 per unitGeneric · +13% in a year
FEMARA 2.5 MG TABLET: $27.12 per unitBrand · +3% in a year
Femara(1) A drug with new indications for the induction of ovulation in patients with polycystic ovary syndrome and with unexplained infertility. · (1) Novartis Pharma K.K. (2) Nippon Kayaku Co., Ltd. (3) Fuji Pharma Co., Ltd. · Sep 16, 2022
FemaraA drug with a new indication and a new dosage for controlled ovarian stimulation in assisted reproductive technology. · Novartis Pharma K.K. · Feb 25, 2022
Clinical Trials
271 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
Strides Pharma Intl
Hikma
Accord Hlthcare
Sun Pharm Inds Ltd
Impax Labs
Eugia Pharma
Zydus Lifesciences
Zydus Pharms USA Inc