Pamidronate Disodium

Treats moderate or severe hypercalcemia associated with malignancy, with or without bone…. ANDA 75841, held by Hospira. Pamidronate Disodium.

As of Nov 15, 2026, ANDA 75841 (Pamidronate Disodium), held by Hospira, was first approved by FDA on Jun 27, 2002, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2002
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hypercalcemia of Malignancy Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 27, 2002	Original application	Approved	Review

Products

3 strengths and forms


Pamidronate Disodium30MG/10ML (3MG/ML) · injectable;injection	Pamidronate Disodium	Rx
Pamidronate Disodium60MG/10ML (6MG/ML) · injectable;injection	Pamidronate Disodium	Rx
Pamidronate Disodium90MG/10ML (9MG/ML) · injectable;injection	Pamidronate Disodium	Rx

All 8 submissions, including labeling and manufacturing supplements


Jan 7, 2020	Supplement 19Labeling · Standard review	Approved	None posted
Jul 15, 2009	Supplement 16Labeling	Approved	None posted
Jul 9, 2008	Supplement 14Labeling	Approved	None posted
Jan 19, 2007	Supplement 10Labeling	Approved	None posted
Jul 14, 2006	Supplement 9Labeling	Approved	None posted
May 19, 2006	Supplement 7Labeling	Approved	None posted
Jan 21, 2005	Supplement 2Labeling	Approved	None posted
Jun 27, 2002	Original application	Approved	Review

Identifiers

Application: ANDA 75841
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters