Overview
Ibandronate, or BM 21.0955, is a third generation, nitrogen containing bisphosphonate similar to zoledronic acid, minodronic acid, and risedronic acid. It is used to prevent and treat postmenopausal osteoporosis. Ibandronate was first described in the literature in 1993 as a treatment for bone loss in dogs. Ibandronate was granted FDA approval on 16 May 2003.
Indication
For the treatment and prevention of osteoporosis in postmenopausal women.
Associated Conditions
- Bone Metastases
- Hypercalcemia of Malignancy
- Osteoporosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/09/01 | Not Applicable | Not yet recruiting | |||
2022/03/04 | Not Applicable | Completed | Yeouido St. Mary's Hospital | ||
2020/03/25 | Phase 2 | Completed | |||
2017/06/14 | Phase 2 | Recruiting | |||
2016/10/31 | Phase 4 | Completed | |||
2016/04/15 | Phase 3 | Terminated | |||
2016/03/23 | Phase 3 | Completed | |||
2015/11/30 | Phase 2 | Completed | |||
2015/11/13 | Phase 4 | Completed | |||
2015/11/06 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Bionpharma Inc. | 69452-378 | ORAL | 150 mg in 1 1 | 5/23/2023 | |
Aurobindo Pharma Limited | 65862-237 | ORAL | 150 mg in 1 1 | 1/31/2024 | |
Golden State Medical Supply, Inc. | 60429-643 | ORAL | 150 mg in 1 1 | 9/25/2023 | |
AuroMedics Pharma LLC | 55150-191 | INTRAVENOUS | 3 mg in 3 mL | 5/5/2022 | |
Macleods Pharmaceuticals Limited | 33342-150 | ORAL | 150 mg in 1 1 | 7/2/2022 | |
Accord Healthcare Inc. | 16729-274 | INTRAVENOUS | 3 mg in 3 mL | 1/9/2024 | |
Apotex Corp | 60505-2795 | ORAL | 150 mg in 1 1 | 9/14/2023 | |
Dr. Reddy's Laboratories Limited | 55111-575 | ORAL | 150 mg in 1 1 | 4/30/2023 | |
Alvogen Inc. | 47781-103 | ORAL | 150 mg in 1 1 | 1/1/2017 | |
Apotex Corp. | 60505-6097 | INTRAVENOUS | 3 mg in 3 mL | 12/14/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 7/26/2011 | ||
Authorised | 2/23/2004 | ||
Authorised | 6/25/1996 | ||
Authorised | 9/17/2010 | ||
Authorised | 11/18/2012 | ||
Authorised | 1/21/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
Bondronat Tablet 50mg | SIN13425P | TABLET, FILM COATED | 50mg | 3/10/2008 | |
BONDRONAT FOR INFUSION 1 mg/ml | SIN11206P | INJECTION | 1mg/ml | 10/29/1999 | |
Bonviva Pre-Filled Syringe 3mg/3ml | SIN13328P | INJECTION, SOLUTION | 3mg/3ml | 8/2/2007 | |
Bonviva Tablet 150 mg | SIN13206P | TABLET, FILM COATED | 168.75 mg | 6/19/2006 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
BONDRONAT ibandronic acid 6mg/6mL (as sodium) injection vial | 98008 | Medicine | A | 4/13/2004 | |
BONDRONAT ibandronic acid 50mg film-coated tablet blister pack | 119673 | Medicine | A | 8/24/2006 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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