Boniva

Product manufactured by Genentech, Inc.

Application Nr Approved Date Route Status External Links
NDA021455 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Boniva Is A Bisphosphonate Indicated For The Treatment And Prevention Of Postmenopausal Osteoporosis. ( 1.1 ). Limitations Of Use The Optimal Duration Of Use Has Not Been Determined. For Patients At Low-Risk For Fracture, Consider Drug Discontinuation After 3 To 5 Years Of Use. ( 1.2 ). 1.1 Treatment And Prevention Of Postmenopausal Osteoporosis Boniva Is Indicated For The Treatment And Prevention Of Osteoporosis In Postmenopausal Women. Boniva Increases Bone Mineral Density (Bmd) And Reduces The Incidence Of Vertebral Fractures. 1.2 Important Limitations Of Use The Optimal Duration Of Use Has Not Been Determined. The Safety And Effectiveness Of Boniva For The Treatment Of Osteoporosis Are Based On Clinical Data Of Three Years Duration. All Patients On Bisphosphonate Therapy Should Have The Need For Continued Therapy Re-Evaluated On A Periodic Basis. Patients At Low-Risk For Fracture Should Be Considered For Drug Discontinuation After 3 To 5 Years Of Use. Patients Who Discontinue Therapy Should Have Their Risk For Fracture Re-Evaluated Periodically.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ibandronate Sodium IBANDRONATE SODIUM ZINC1533877

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