FDA — authorised 11 August 2000
- Application: NDA021197
- Marketing authorisation holder: EMD SERONO INC
- Status: supplemented
🇺🇸 Cetrotide in United States
FDA authorised Cetrotide on 11 August 2000 · 392 US adverse-event reports
Marketing authorisations
FDA — authorised 12 August 2022
- Application: ANDA215737
- Marketing authorisation holder: TEVA PHARMS INC
- Local brand name: CETRORELIX ACETATE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 16 April 2024
- Application: ANDA217776
- Marketing authorisation holder: QILU
- Local brand name: CETRORELIX ACETATE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 25 April 2024
- Application: ANDA218150
- Marketing authorisation holder: GLAND
- Local brand name: CETRORELIX ACETATE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA — authorised 29 April 2026
- Application: ANDA218740
- Marketing authorisation holder: HUMANWELL
- Local brand name: CETRORELIX ACETATE
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
FDA
- 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: 392
Most-reported reactions
- Ovarian Hyperstimulation Syndrome — 134 reports (34.18%)
- Premature Ovulation — 42 reports (10.71%)
- Abortion Spontaneous — 38 reports (9.69%)
- Ascites — 33 reports (8.42%)
- Drug Ineffective — 32 reports (8.16%)
- Abdominal Pain — 27 reports (6.89%)
- Abdominal Distension — 24 reports (6.12%)
- Nausea — 23 reports (5.87%)
- Off Label Use — 20 reports (5.1%)
- Dizziness — 19 reports (4.85%)
Cetrotide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Cetrotide approved in United States?
Yes. FDA authorised it on 11 August 2000; FDA authorised it on 12 August 2022; FDA authorised it on 16 April 2024.
Who is the marketing authorisation holder for Cetrotide in United States?
EMD SERONO INC holds the US marketing authorisation.