Binosto

Product manufactured by Ascend Therapeutics

Application Nr Approved Date Route Status External Links
NDA202344 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Binosto Is A Bisphosphonate Indicated For: Treatment Of Osteoporosis In Postmenopausal Women ( 1.1 ) Treatment To Increase Bone Mass In Men With Osteoporosis ( 1.2 ) Limitation Of Use: 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. ( 1.3 ) 1.1 Treatment Of Osteoporosis In Postmenopausal Women Binosto Effervescent Tablet 70 Mg Is Indicated For The Treatment Of Osteoporosis In Postmenopausal Women. For The Treatment Of Osteoporosis, Alendronate Sodium Increases Bone Mass And Reduces The Incidence Of Fractures, Including Those Of The Hip And Spine (Vertebral Compression Fractures). [See Clinical Studies ( 14.1 ).] 1.2 Treatment To Increase Bone Mass In Men With Osteoporosis Binosto Is Indicated For Treatment To Increase Bone Mass In Men With Osteoporosis [See Clinical Studies ( 14.2 )] . 1.3 Important Limitations Of Use The Optimal Duration Of Use Has Not Been Determined. The Safety And Effectiveness Of Binosto For The Treatment Of Osteoporosis Are Based On Clinical Data Of Four 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. Alendronate Sodium ALENDRONATE SODIUM ZINC3801919

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