Valrubicin

Overview

Valrubicin (N-trifluoroacetyladriamycin-14-valerate) is a chemotherapy drug commonly marketed under the trade name VALSTAR. It is a semisynthetic analog of the doxorubicin, which is an anthracycline drug. Used in the treatment of the bladder cancer, valrubicin is administered by direct infusion into the bladder.

Indication

For the treatment of cancer of the bladder.

Associated Conditions

In situ BCG-refractory Bladder carcinoma

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase I Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma	2012/05/25	NCT01606345	Phase 1	Completed	H. Lee Moffitt Cancer Center and Research Institute
Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder	2011/03/09	NCT01310803	Phase 3	Terminated	Endo Pharmaceuticals
Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer	2004/07/22	NCT00003725	Phase 3	UNKNOWN	Anthra Pharmaceuticals
AD 32 With or Without BCG After Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer	2003/07/18	NCT00003759	Phase 2	Completed	Anthra Pharmaceuticals
Chemotherapy in Treating Patients With Early-Stage Bladder Cancer	2003/04/18	NCT00003129	Phase 2	Completed	Eastern Cooperative Oncology Group

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Valstar	Endo Pharmaceuticals Solutions Inc.	67979-001	INTRAVESICAL	40 mg in 1 mL	10/25/2023
Valrubicin Intravesical Solution	Hikma Pharmaceuticals USA Inc.	24201-101	INTRAVESICAL	40 mg in 1 mL	6/30/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
VALTAXIN	ENDO PHARMACEUTICALS SOLUTIONS INC	02242466	Solution - Intravesical	40 MG / ML	4/23/2001

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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