FDA — authorised 3 June 2011
- Application: ANDA090289
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 LETROZOLE in United States
FDA authorised LETROZOLE on 3 June 2011 · 35,431 US adverse-event reports
Marketing authorisations
FDA — authorised 3 June 2011
- Application: ANDA090491
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA090838
- Marketing authorisation holder: HIKMA
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA201804
- Marketing authorisation holder: INDICUS PHARMA
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA200161
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA090789
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA090934
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA091191
- Marketing authorisation holder: CARNEGIE
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA091466
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2011
- Application: ANDA091098
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 2018
- Application: ANDA205869
- Marketing authorisation holder: BEIJING YILING
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 2019
- Application: ANDA211717
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA215975
- Marketing authorisation holder: MSN LABS PVT LTD
- Local brand name: LETROZOLE;VRIBOCICLIB SUCCINATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA090196
- Marketing authorisation holder: SYNTHON PHARMS
- Local brand name: LETROZOLE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 35,431
Most-reported reactions
- Fatigue — 5,896 reports (16.64%)
- Neutropenia — 4,338 reports (12.24%)
- Nausea — 4,274 reports (12.06%)
- Diarrhoea — 3,731 reports (10.53%)
- Malignant Neoplasm Progression — 3,520 reports (9.93%)
- White Blood Cell Count Decreased — 3,170 reports (8.95%)
- Arthralgia — 2,916 reports (8.23%)
- Alopecia — 2,783 reports (7.85%)
- Neoplasm Progression — 2,523 reports (7.12%)
- Dyspnoea — 2,280 reports (6.44%)
LETROZOLE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is LETROZOLE approved in United States?
Yes. FDA authorised it on 3 June 2011; FDA authorised it on 3 June 2011; FDA authorised it on 3 June 2011.
Who is the marketing authorisation holder for LETROZOLE in United States?
TEVA PHARMS holds the US marketing authorisation.