Pamidronate Disodium

Sold as Aredia, Pamidronate Disodium. Every FDA application for this active ingredient: 3 branded and 13 generic.

As of Nov 15, 2026, FDA lists 16 applications for Pamidronate Disodium (sold as Aredia, Pamidronate Disodium), first approved Oct 31, 1991, with 6 new uses approved and 0 published complete response letters.

First approved: Oct 31, 1991
Applications: 16
New uses approved: 6
Complete response letters: 0
Medicare spending, 2025: $27K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Pamidronate Disodium	Part B	$19K	-9%	235
Pamidronate Disodium	Part D	$8K	-32%	78

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

ArediaDrugs with a new additional indication and a new dosage for the treatment of osteogenesis imperfecta. · Novartis Pharma K.K. · May 23, 2014

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


CHronic Nonbacterial Osteomyelitis International RegistryChronic Nonbacterial Osteomyelitis, Chronic Recurrent Multifocal Osteomyelitis · Seattle Children's Hospital	—	Recruiting	Jan 26, 2021
Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate CancerBreast Cancer, Castration-resistant Prostate Cancer · Ottawa Hospital Research Institute	Phase 4	Active, not recruiting	Sep 16, 2020

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 31, 1991	ArediaNDA 20036 · New molecular entity	Novartis	32	Discontinued
Sep 22, 1998	ArediaNDA 20927 · TYPE 6	Novartis	0	Marketed
Apr 30, 2001	Pamidronate DisodiumANDA 75290	Hikma	9	Marketed
Mar 4, 2002	Pamidronate DisodiumNDA 21113 · New formulation or manufacturer	Hikma	7	Marketed
Mar 27, 2002	Pamidronate DisodiumANDA 76153	Teva Pharms USA	4	Discontinued
May 6, 2002	Pamidronate DisodiumANDA 75594	Aesgen	0	Discontinued
May 6, 2002	Pamidronate DisodiumANDA 75773	Fresenius Kabi USA	1	Discontinued
May 17, 2002	Pamidronate DisodiumANDA 76207	Fresenius Kabi USA	7	Discontinued
Jun 27, 2002	Pamidronate DisodiumANDA 75841	Hospira	7	Marketed
Jul 25, 2008	Pamidronate DisodiumANDA 78942	Am Regent	2	Discontinued
Aug 19, 2008	Pamidronate DisodiumANDA 78156	Dr Reddys	2	Marketed
Oct 31, 2008	Pamidronate DisodiumANDA 78520	Mylan Labs Ltd	1	Marketed
Nov 26, 2008	Pamidronate DisodiumANDA 77433	Areva Pharms	2	Marketed
Dec 23, 2008	Pamidronate DisodiumANDA 78373	Sagent Pharms Inc	3	Marketed
Dec 24, 2008	Pamidronate DisodiumANDA 77703	Sun Pharma Global	0	Discontinued
Mar 10, 2009	Pamidronate DisodiumANDA 78300	Mn Pharms	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA