CETRORELIX ACETATE · Teva
Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
Details
- Status
- Prescription
- First Approved
- 2000-08-11
- Routes
- SUBCUTANEOUS
- Dosage Forms
- POWDER
CETRORELIX ACETATE Approval History
What CETRORELIX ACETATE Treats
1 indicationsCETRORELIX ACETATE is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Premature Luteinizing Hormone Surge
CETRORELIX ACETATE Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07340827 | MS132705_0007 jRCT2031250671 | Ph 3 | recruiting | A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA) |
| NCT03181685 | Andros Day Surgery Clinic | Ph 4 | terminated | Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles |
| NCT01185704 ATTAC-PCO results posted | EMR200088-501 2007-007932-25, INI 28091 | Ph 3 | completed | Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CETRORELIX ACETATE FDA Label Details
Indications & Usage
Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
Looking for the branded version?
CETROTIDE
Full clinical data, patents, trials, and competitive landscape for cetrorelix acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.