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Details for Generic Name: cetrorelix

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Cetrorelix is the generic ingredient in one branded drug marketed by Emd Serono Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for cetrorelix. One supplier is listed for this compound.

Summary for Generic Name: cetrorelix

Drug Master File Entries: see list1
Suppliers: see list1
Formulation / Manufacturing:see details

Clinical Trials for: cetrorelix

Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Status: Completed Condition: Benign Prostatic Hypertrophy

Cetrorelix Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Status: Terminated Condition: Benign Prostatic Hypertrophy

Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Status: Completed Condition: Benign Prostatic Hypertrophy

Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
Status: Completed Condition: Polycystic Ovarian Syndrome

An Observational Study of Cetrotide® Gonadotropin-releasing Hormone Antagonist (GnRH Antagonist) With GONAL-f® in Assisted Reproductive Technologies (ART)
Status: Completed Condition: Infertility

Cetrotide Treatment Optimization
Status: Terminated Condition: In Vitro Fertilization; Intracytoplasmic Sperm Injection

A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation
Status: Completed Condition: Infertile Women Undergoing Assisted Reproductive Technology (ART)

A Multinational, Randomized, Double-Blind, Placebo‑Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis
Status: Completed Condition: Endometriosis

The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors
Status: Completed Condition: Ovarian Hyperstimulation Syndrome

Clinical Pharmacological Study of GnRH Antagonist, Cetrorelix for Healthy Female Volunteer
Status: Completed Condition: Premenopause

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emd Serono Inc
INJECTABLE;INJECTION021197-002Aug 11, 2000DISCNNo6,319,192<disabled><disabled>
Emd Serono Inc
INJECTABLE;INJECTION021197-001Aug 11, 2000RXYes6,319,192<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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