Application Nr Approved Date Route Status External Links
NDA021223 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zometa Is A Bisphosphonate Indicated For The Treatment Of: Hypercalcemia Of Malignancy ( 1.1 ) Patients With Multiple Myeloma And Patients With Documented Bone Metastases From Solid Tumors, In Conjunction With Standard Antineoplastic Therapy. Prostate Cancer Should Have Progressed After Treatment With At Least One Hormonal Therapy. ( 1.2 ) Limitations Of Use : The Safety And Efficacy Of Zometa Has Not Been Established For Use In Hyperparathyroidism Or Non-Tumor-Related Hypercalcemia. 1.1 Hypercalcemia Of Malignancy Zometa Is Indicated For The Treatment Of Hypercalcemia Of Malignancy Defined As An Albumin-Corrected Calcium (Cca) Of Greater Than Or Equal To 12 Mg/dl [3.0 Mmol/l] Using The Formula: Cca In Mg/dl = Ca In Mg/dl + 0.8 (4.0 G/dl - Patient Albumin [G/dl]). 1.2 Multiple Myeloma And Bone Metastases Of Solid Tumors Zometa Is Indicated For The Treatment Of Patients With Multiple Myeloma And Patients With Documented Bone Metastases From Solid Tumors, In Conjunction With Standard Antineoplastic Therapy. Prostate Cancer Should Have Progressed After Treatment With At Least One Hormonal Therapy. Limitations Of Use The Safety And Efficacy Of Zometa In The Treatment Of Hypercalcemia Associated With Hyperparathyroidism Or With Other Non–tumor-Related Conditions Have Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Zoledronic Acid ZOLEDRONIC ACID ZINC4501392

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