Pamidronate Disodium

For moderate to severe Paget’s disease of bone. ANDA 78520, held by Mylan Labs Ltd. Pamidronate Disodium.

As of Nov 15, 2026, ANDA 78520 (Pamidronate Disodium), held by Mylan Labs Ltd, was first approved by FDA on Oct 31, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 31, 2008
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pamidronate disodium is a bisphosphonate indicated for the treatment of:

moderate or severe hypercalcemia associated with malignancy, with or without bone metastases
patients with moderate to severe Paget’s disease of bone
osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy Limitations of use Safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 31, 2008	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


May 13, 2009	Supplement 1Labeling	Approved	None posted
Oct 31, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78520
Drugs@FDA: Overview at FDA
Company: Mylan Laboratories

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