Regulatory PathRegulatory requirements compared

Active substance

Letrozole

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
FEMAPLEX 2.5 mg film-coated tablet2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 136.55Generic · PrescriptionGENEPHARM S.A.Valid
FEMARA 2.5 MG TABLET2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 183.55NCE · PrescriptionNOVARTIS PHARMA AGValid
LETARA 2.5 mg tablet2.5 mgFilm-coated tablet · Oral use30 Single Dose ContainerSAR 156.55Generic · PrescriptionDOUGLAS MANUFACTURING LtdValid
ROZLET 2.5 MG FILM COATED TABLET2.5 mgFilm-coated tablet · Oral use10 BlisterSAR 56.20Generic · PrescriptionSPIMACO ADDWAEIHValid
ROZLET 2.5 mg film-coated tablet2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 165.20Generic · PrescriptionSPIMACO ADDWAEIHValid
TREZOL 2.5 mg film-coated tablet2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 165.20Generic · PrescriptionLABORATORIOS CINFA SAValid
XOROLA 2.5MG F.C.TABLET2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 115.65Generic · PrescriptionBoston Oncology ArabiaValid
LETRASAN 2.5MG F.C.TABLET2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 68.45Generic · PrescriptionDEVA HOLDING A.S.Suspended
FEMARA 2.5 MG TABLET2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 506.85NCE · PrescriptionNOVARTISWithdrawn by MAH · Not Marketed
LEFFTARA 2.5 mg film-coated tablet2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 168.60Generic · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
LEZODEX 2.5 mg tablet2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 165.20Generic · PrescriptionAPOTEXWithdrawn by MAH · Not Marketed
LOXOPREL 2.5 mg film-coated tablet2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 261.70Generic · PrescriptionACTAVISWithdrawn by MAH · Not Marketed
MARLET 2.5 MG F.C. TABLET2.5 mgFilm-coated tablet · Oral use30 BlisterSAR 165.20Generic · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BREAST CANCER EARLY HORMONAL; BREAST CANCER MET.HORMONAL; ENDOMETRIOSIS; OVARIAN CANCER

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
FEMARA2.5MGtablet · oralNOVARTIS PHARMSPrescription25 Jul 1997
LETROZOLE2.5MGtablet · oralTEVA PHARMSPrescription3 Jun 2011
LETROZOLE2.5MGtablet · oralACCORD HLTHCAREPrescription3 Jun 2011
LETROZOLE2.5MGtablet · oralPHARMOBEDIENTPrescription3 Jun 2011
LETROZOLE2.5MGtablet · oralNATCO PHARMA LTDPrescription3 Jun 2011
LETROZOLE2.5MGtablet · oralBEIJING YILINGPrescription14 Nov 2018
LETROZOLE2.5MGtablet · oralEUGIA PHARMAPrescription11 Jan 2019
LETROZOLE2.5MGtablet · oralZYDUS LIFESCIENCESPrescription14 Sep 2026
LETROZOLE2.5MGtablet · oralPHARMOBEDIENTDiscontinued24 Dec 2008
LETROZOLE2.5MGtablet · oralFRESENIUS KABI USADiscontinued3 Jun 2011
LETROZOLE2.5MGtablet · oralSTRIDES PHARMA INTLDiscontinued3 Jun 2011
LETROZOLE2.5MGtablet · oralHIKMA PHARMSDiscontinued3 Jun 2011
LETROZOLE2.5MGtablet · oralLANNETT CO INCDiscontinued3 Jun 2011
LETROZOLE2.5MGtablet · oralSUN PHARM INDS LTDDiscontinued3 Jun 2011
LETROZOLE2.5MGtablet · oralIMPAX LABSDiscontinued3 Jun 2011
LETROZOLE2.5MGtablet · oralINDICUS PHARMADiscontinued3 Jun 2011
LETROZOLE2.5MGtablet · oralACTAVIS TOTOWADiscontinued13 Jul 2011
LETROZOLE2.5MGtablet · oralAPOTEX INCDiscontinued19 Apr 2012
LETROZOLE2.5MGtablet · oralCHARTWELL RXDiscontinued16 May 2013
LETROZOLE2.5MGtablet · oralLANNETT CO INCDiscontinued29 Oct 2014
LETROZOLE2.5MGtablet · oralHIKMA PHARMSDiscontinued3 Jun 2016
LETROZOLE2.5MGtablet · oralSYNTHON PHARMSDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACH-LETROZOLE023384592.5 MGTABLET · ORALACCORD HEALTHCARE INC
AG-LETROZOLE TABLETS025434192.5 MGTABLET · ORALANGITA PHARMA INC.
APO-LETROZOLE023585142.5 MGTABLET · ORALAPOTEX INC
BIO-LETROZOLE023924962.5 MGTABLET · ORALBIOMED PHARMA
FEMARA022313842.5 MGTABLET · ORALNOVARTIS PHARMACEUTICALS CANADA INC
JAMP LETROZOLE TABLETS025419122.5 MGTABLET · ORALJAMP PHARMA CORPORATION
LETROZOLE024020252.5 MGTABLET · ORALPRO DOC LIMITEE
LETROZOLE025044722.5 MGTABLET · ORALSANIS HEALTH INC
LETROZOLE025242442.5 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
M-LETROZOLE025499722.5 MGTABLET · ORALMANTRA PHARMA INC
MAR-LETROZOLE023734242.5 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MINT-LETROZOLE025081092.5 MGTABLET · ORALMINT PHARMACEUTICALS INC
NAT-LETROZOLE024215852.5 MGTABLET · ORALNATCO PHARMA (CANADA) INC
NRA-LETROZOLE025204862.5 MGTABLET · ORALNORA PHARMA INC
PMS-LETROZOLE023091142.5 MGTABLET · ORALPHARMASCIENCE INC
RIVA-LETROZOLE023986562.5 MGTABLET · ORALLABORATOIRE RIVA INC.
SANDOZ LETROZOLE023448152.5 MGTABLET · ORALSANDOZ CANADA INCORPORATED
TEVA-LETROZOLE023436572.5 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFEMARA 2.5 MG TABLET$27.11602per EA7 Jan 2026
US NADACLETROZOLE 2.5 MG TABLET$0.14498per EA23 Sep 2026
NHS Drug TariffLetrozole 2.5mg tablets£2.1428 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 22.2. Ovulation inducers · complementary
    Female infertility without specification whether primary or secondary
    Oral > Solid > dosage form: 2.5 mg

Safety signals and safety-related labeling changes

  • US FDA 1 Jul 2026 KISQALI FEMARA CO-PACK (COPACKAGED) — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 16 Dec 2024 FEMARA — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for letrozole →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.