Overview
Risedronic acid is a third generation bisphosphonate that is used for the treatment of some forms of osteoperosis and Paget's disease. It functions by preventing resorption of bone.
Background
Risedronic acid is a third generation bisphosphonate that is used for the treatment of some forms of osteoperosis and Paget's disease. It functions by preventing resorption of bone.
Indication
Risedronic acid is indicated for the treatment of osteoperosis in men, treatment of Paget's disease, treatment and prevention of osteoperosis in postmenopausal women, and treatment and prevention of glucocorticoid-induced osteoperosis.
Associated Conditions
- Hypercalcemia of Malignancy
- Osteoporosis
- Paget’s Disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/11/30 | Phase 4 | Active, not recruiting | |||
2022/04/26 | Not Applicable | Completed | Hospital Regional 1o de Octubre | ||
2021/06/10 | Phase 3 | Recruiting | |||
2021/05/10 | N/A | Completed | |||
2019/11/05 | Phase 4 | Recruiting | Hospital for Special Surgery, New York | ||
2019/03/04 | Phase 2 | Completed | |||
2018/01/26 | Phase 4 | Completed | |||
2017/07/05 | Phase 2 | Completed | |||
2016/04/20 | Phase 3 | Terminated | University Hospital, Limoges | ||
2014/07/10 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Allergan, Inc. | 0430-0979 | ORAL | 30.1 mg in 1 1 | 10/27/2023 | |
| Sun Pharmaceutical Industries, Inc. | 47335-666 | ORAL | 5 mg in 1 1 | 9/6/2023 | |
| Greenstone LLC | 59762-0405 | ORAL | 30.1 mg in 1 1 | 1/10/2024 | |
| Apotex Corp. | 60505-3096 | ORAL | 75 mg in 1 1 | 12/15/2023 | |
| Allergan, Inc. | 0430-0472 | ORAL | 30.1 mg in 1 1 | 11/21/2023 | |
| Proficient Rx LP | 71205-714 | ORAL | 35 mg in 1 1 | 11/1/2022 | |
| Sun Pharmaceutical Industries, Inc. | 47335-727 | ORAL | 75 mg in 1 1 | 9/6/2023 | |
| Macleods Pharmaceuticals Limited | 33342-108 | ORAL | 30 mg in 1 1 | 8/1/2023 | |
| Aurobindo Pharma Limited | 65862-518 | ORAL | 30 mg in 1 1 | 1/31/2024 | |
| NorthStar RxLLC | 16714-870 | ORAL | 35 mg in 1 1 | 9/17/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ACTONEL ONCE-A-WEEK TABLET 35 mg | SIN12284P | TABLET, FILM COATED | 35 mg | 4/30/2003 | |
| Actonel® Once -a-Month Film Coated Tablet 150mg | SIN13948P | TABLET, FILM COATED | 150mg | 4/18/2011 | |
| INDRONATE FILM-COATED TABLET 35 MG | SIN14439P | TABLET, FILM COATED | 35mg | 11/14/2013 | |
| Risedronate Mevon film-coated tablets 35mg | SIN13798P | TABLET, FILM COATED | 35 mg | 5/14/2010 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Risedronate Sodium Capsules | 国药准字H20100136 | 化学药品 | 胶囊剂 | 7/14/2020 | |
| Risedronate Sodium Tablets | 国药准字H20080566 | 化学药品 | 片剂 | 5/30/2023 | |
| Risedronate Sodium Tablets | 国药准字H20140091 | 化学药品 | 片剂 | 1/6/2023 | |
| Risedronate Sodium Tablets | 国药准字H20040391 | 化学药品 | 片剂 | 8/17/2020 | |
| Risedronate Sodium Tablets | 国药准字H20080127 | 化学药品 | 片剂 | 12/20/2022 | |
| Risedronate Sodium Tablets | 国药准字H20080119 | 化学药品 | 片剂 | 1/6/2023 | |
| Risedronate Sodium Tablets | 国药准字H20080518 | 化学药品 | 片剂 | 2/4/2024 | |
| Risedronate Sodium Tablets | 国药准字H20051021 | 化学药品 | 片剂 | 1/9/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| APO-RISEDRONATE TABLETS 35MG | N/A | hind wing co ltd | N/A | N/A | 6/21/2013 |