IBANDRONATE SODIUM

Pre-Launch

ibandronate sodium

Entera Bio

ANDAORALTABLET

Lifecycle

Pre-Launch

Clinical Trials

Data completeness

3/8 — Basic

IBANDRONATE SODIUM (ibandronate sodium) by Entera Bio is hydroxyapatite, which is part of the mineral matrix of bone. Approved for osteoporosis in postmenopausal women.

Drug data last refreshed 1mo ago

Mechanism of Action

hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

Indications (1)

osteoporosis in postmenopausal women

Clinical Trials (1)

NCT01627886Phase 1Completed

Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition

Started Sep 2008

100 enrolled

Healthy

Company

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.