Pamidronic acid

Overview

Pamidronic acid is a second generation, nitrogen containing bisphosphonate similar to neridronic acid and alendronic acid. Pamidronic acid was first described in the literature in 1977. The second generation bisphosphonates are less common as third generation bisphosphonates, such as ibandronic acid, zoledronic acid, minodronic acid, and risedronic acid are becoming more popular. Pamidronic acid was granted FDA approval on 31 October 1991.

Indication

Pamidronate is indicated to treat moderate to severe hypercalcemia of malignancy, moderate to severe Paget's disease of bone, osteolytic bone metastases of breast cancer, and osteolytic lesions of multiple myeloma.

Associated Conditions

Hypercalcemia of Malignancy
Osteolytic lesion
Paget’s Disease
Osteolytic Bone metastases

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
CHronic Nonbacterial Osteomyelitis International Registry	2021/01/26	NCT04725422	N/A	Recruiting	Seattle Children's Hospital
Bisphosphonate Therapy in MONA Spectrum Disorder	2016/07/06	NCT02823925	N/A	Completed	Medical University Innsbruck
4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases	2016/03/29	NCT02721433	Phase 4	Completed	Ottawa Hospital Research Institute
Efficacy of Bisphosphonates in Patients With Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) Syndrome	2015/09/09	NCT02544659	Phase 1	Completed	Peking Union Medical College Hospital
Combined Treatment With TNF Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression	2014/12/10	NCT02313727	Phase 4	UNKNOWN	Bnai Zion Medical Center
Evaluate Time Associated With the Preparation & Administration of Denosumab/Pamidronate in Patients With Solid Tumors and Metastatic Bone Disease	2014/04/02	NCT02101164	Phase 4	Withdrawn	Amgen
Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation	2014/02/28	NCT02074631	Phase 2	Completed	Masonic Cancer Center, University of Minnesota
The Use of Bisphosphonates in the Treatment of Avascular Necrosis of the Femoral Head	2013/12/11	NCT02007915	Not Applicable	Terminated	The Hospital for Sick Children
The ODYSSEY TRIAL Phase IV Trial Evaluating the Palliative Benefit of Pamidronate or Zoledronic Acid in Breast Cancer	2013/07/25	NCT01907880	Phase 4	Completed	Ottawa Hospital Research Institute
Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease	2013/02/27	NCT01799616	Phase 2	UNKNOWN	University Hospital, Clermont-Ferrand

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Pamidronate Disodium	Areva Pharmaceuticals Inc.	59923-602	INTRAVENOUS	6 mg in 1 mL	1/14/2021
Pamidronate Disodium	Hospira, Inc.	61703-326	INTRAVENOUS	9 mg in 1 mL	12/19/2023
Pamidronate Disodium	Mylan Institutional LLC	67457-430	INTRAVENOUS	3 mg in 1 mL	12/6/2018
Pamidronate Disodium	Hospira, Inc.	61703-324	INTRAVENOUS	3 mg in 1 mL	12/19/2023
Pamidronate Disodium	Areva Pharmaceuticals Inc.	59923-603	INTRAVENOUS	9 mg in 1 mL	1/14/2021
Pamidronate Disodium	Mylan Institutional LLC	67457-446	INTRAVENOUS	9 mg in 1 mL	12/6/2018
Pamidronate Disodium	Areva Pharmaceuticals Inc.	59923-601	INTRAVENOUS	3 mg in 1 mL	1/14/2021
Pamidronate Disodium	Hospira, Inc.	61703-325	INTRAVENOUS	6 mg in 1 mL	12/19/2023

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
PAMISOL CONCENTRATED INJECTION 30 mg/10 ml	Hospira Australia Pty Ltd	SIN11543P	INJECTION	3 mg/ml	6/6/2001

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
Hospira Pamidronate Disodium Injection 90 mg/10 mL vial	123484	Hospira Australia Pty Ltd	Medicine	A	11/10/2005
Pfizer Pamidronate Disodium Concentrated Injection 15 mg/5 mL vial - EU	425372	Hospira Australia Pty Ltd	Medicine	A	10/13/2023
Hospira Pamidronate Disodium Injection 30 mg/10 mL vial	123485	Hospira Australia Pty Ltd	Medicine	A	11/10/2005
Hospira pamidronate disodium Concentrated Injection 60 mg/10 mL vial	121425	Hospira Australia Pty Ltd	Medicine	A	8/22/2005
PAMISOL pamidronate disodium 90mg/10mL injection vial	75109	Pfizer Australia Pty Ltd	Medicine	A	8/1/2000
Hospira pamidronate disodium Concentrated Injection 15 mg/5 mL vial	121423	Hospira Australia Pty Ltd	Medicine	A	8/22/2005
PAMISOL pamidronate disodium 60mg/10mL injection vial	75108	Pfizer Australia Pty Ltd	Medicine	A	8/1/2000
PAMISOL pamidronate disodium 15mg/5mL injection vial	75106	Pfizer Australia Pty Ltd	Medicine	A	8/1/2000
Hospira pamidronate disodium Concentrated Injection 90 mg/10 mL vial	119064	Hospira Australia Pty Ltd	Medicine	A	5/5/2005
Hospira pamidronate disodium Concentrated Injection 30 mg/10 mL vial	121424	Hospira Australia Pty Ltd	Medicine	A	8/22/2005

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AREDIA LIQ INJ 3MG/ML	geigy pharmaceuticals, ciba-geigy canada ltd.	01974491	Liquid - Intravenous	3 MG / ML	12/31/1992
AREDIA	novartis pharmaceuticals canada inc	02059770	Powder For Solution - Intravenous	60 MG / VIAL	12/31/1994
PAMIDRONATE DISODIUM FOR INJECTION	Pfizer Canada Ulc	02244550	Solution - Intravenous	3 MG / ML	8/31/2001
PAMIDRONATE DISODIUM FOR INJECTION	Pfizer Canada Ulc	02244552	Solution - Intravenous	9 MG / ML	8/31/2001
PMS-PAMIDRONATE	Pharmascience Inc	02245999	Powder For Solution - Intravenous	90 MG / VIAL	4/23/2003
PAMIDRONATE DISODIUM OMEGA 6 MG/ML	omega laboratories limited	02249677	Solution - Intravenous	6 MG / ML	5/24/2006
VAL-PAMIDRONATE DISODIUM	Valeo Pharma Inc	02382032	Solution - Intravenous	9 MG / ML	11/1/2012
PAMIDRONATE DISODIUM OMEGA 3 MG/ML	omega laboratories limited	02249669	Solution - Intravenous	3 MG / ML	4/18/2007
AREDIA 90MG	novartis pharmaceuticals canada inc	02059789	Powder For Solution - Intravenous	90 MG / VIAL	12/31/1994
PAMIDRONATE DISODIUM FOR INJECTION	fresenius kabi canada ltd	02246599	Solution - Intravenous	9 MG / ML	3/1/2004

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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