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Profile for Tradename: CAMPTOSAR

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Camptosar is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in CAMPTOSAR is irinotecan hydrochloride. There are thirty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Summary for Tradename: CAMPTOSAR

Suppliers / Packagers: see list7

Pharmacology for Tradename: CAMPTOSAR

Clinical Trials for: CAMPTOSAR

Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas
Status: Terminated Condition: Sarcoma

Irinotecan (Camptosar) in Patients With Advanced Sarcomas
Status: Completed Condition: Sarcoma

Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas
Status: Terminated Condition: Astrocytoma; Glioma; Oligodendroglioma

Talazoparib Plus Irinotecan With or Without Temozolomide in Children With Refractory or Recurrent Solid Malignancies
Status: Recruiting Condition: Childhood Solid Tumors

Panitumumab and Irinotecan for Malignant Gliomas
Status: Terminated Condition: Malignant Glioma of Brain

Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis
Status: Recruiting Condition: Colorectal Cancer

Irinotecan Plus Lenalidomide in Adult Patients With Recurrent Glioblastoma Multiforme: Phase I
Status: Terminated Condition: Malignant Gliomas

A Pilot Study of Irinotecan in Patients With Breast Cancer and CNS Metastases
Status: Withdrawn Condition: Central Nervous System Metastases; Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients
Status: Recruiting Condition: Small Cell Lung Carcinoma; Non Small Cell Lung Carcinoma; Irinotecan Sensitive Cancers

A Phase I Trial of Nanoliposomal CPT-11 (NL CPT-11) in Patients With Recurrent High-Grade Gliomas
Status: Completed Condition: Glioblastoma; Gliosarcoma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma

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See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Inc
irinotecan hydrochloride
INJECTABLE;INJECTION020571-001Jun 14, 1996RXYes6,794,370*PED<disabled>Y<disabled>
Pfizer Inc
irinotecan hydrochloride
INJECTABLE;INJECTION020571-002Jun 14, 1996RXYes6,403,569*PED<disabled>Y<disabled>
Pfizer Inc
irinotecan hydrochloride
INJECTABLE;INJECTION020571-001Jun 14, 1996RXYes6,403,569*PED<disabled>Y<disabled>
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Paragraph IV activity for: CAMPTOSAR

Drugname Dosage Strength RLD Submissiondate
irinotecan hydrochlorideInjection20 mg/mL, 2 mL and 5 mL vialsCamptosar7/26/2004
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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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