Application Nr Approved Date Route Status External Links
ANDA075710 2008-02-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Alendronate Sodium Tablets Are A Bisphosphonate Indicated For: •treatment And Prevention Of Osteoporosis In Postmenopausal Women (1.1, 1.2) •treatment To Increase Bone Mass In Men With Osteoporosis (1.3) •treatment Of Glucocorticoid-Induced Osteoporosis (1.4) •treatment Of Paget's Disease Of Bone (1.5) Limitations 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. (1.6) 1.1 Treatment Of Osteoporosis In Postmenopausal Women Alendronate Sodium Tablets Are Indicated For The Treatment Of Osteoporosis In Postmenopausal Women. In Postmenopausal Women, Alendronate Sodium Tablets Increase 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 Prevention Of Osteoporosis In Postmenopausal Women Alendronate Sodium Tablets Are Indicated For The Prevention Of Postmenopausal Osteoporosis [see Clinical Studies (14.2)]. 1.3 Treatment To Increase Bone Mass In Men With Osteoporosis Alendronate Sodium Tablets Are Indicated For Treatment To Increase Bone Mass In Men With Osteoporosis [see Clinical Studies (14.3)]. 1.4 Treatment Of Glucocorticoid-Induced Osteoporosis Alendronate Sodium Tablets Are Indicated For The Treatment Of Glucocorticoid-Induced Osteoporosis In Men And Women Receiving Glucocorticoids In A Daily Dosage Equivalent To 7.5 Mg Or Greater Of Prednisone And Who Have Low Bone Mineral Density [see Clinical Studies (14.4)]. 1.5 Treatment Of Paget's Disease Of Bone Alendronate Sodium Tablets Are Indicated For The Treatment Of Paget’s Disease Of Bone In Men And Women. Treatment Is Indicated In Patients With Paget's Disease Of Bone Who Have Alkaline Phosphatase At Least Two Times The Upper Limit Of Normal, Or Those Who Are Symptomatic, Or Those At Risk For Future Complications From Their Disease [see Clinical Studies (14.5)]. 1.6 Important Limitations Of Use The Optimal Duration Of Use Has Not Been Determined. The Safety And Effectiveness Of Alendronate Sodium Tablets 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 (2 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Alendronate Sodium ALENDRONATE SODIUM ZINC3801919

Comments