Exemestane

Product manufactured by Greenstone Llc

Application Nr Approved Date Route Status External Links
NDA020753 1999-10-21 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Exemestane Is An Aromatase Inhibitor Indicated For: Adjuvant Treatment Of Postmenopausal Women With Estrogen-Receptor Positive Early Breast Cancer Who Have Received Two To Three Years Of Tamoxifen And Are Switched To Exemestane For Completion Of A Total Of Five Consecutive Years Of Adjuvant Hormonal Therapy (14.1). Treatment Of Advanced Breast Cancer In Postmenopausal Women Whose Disease Has Progressed Following Tamoxifen Therapy (14.2). 1.1 Adjuvant Treatment Of Postmenopausal Women Exemestane Is Indicated For Adjuvant Treatment Of Postmenopausal Women With Estrogen-Receptor Positive Early Breast Cancer Who Have Received Two To Three Years Of Tamoxifen And Are Switched To Exemestane For Completion Of A Total Of Five Consecutive Years Of Adjuvant Hormonal Therapy [see Clinical Studies (14.1)]. 1.2 Advanced Breast Cancer In Postmenopausal Women Exemestane Is Indicated For The Treatment Of Advanced Breast Cancer In Postmenopausal Women Whose Disease Has Progressed Following Tamoxifen Therapy [see Clinical Studies (14.2)].

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
2. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
3. Hypromelloses HYPROMELLOSES Unresolved
4. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. 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.
7. Simethicone SIMETHICONE Unresolved
8. Polyethylene Glycol 6000 POLYETHYLENE GLYCOL 6000 Unresolved
9. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
10. Magnesium Carbonate MAGNESIUM CARBONATE Molecular B&N-Buffer & neutralizing agent FS-Substances permitted as optional ingredient in a standardized food.
11. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
12. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Exemestane EXEMESTANE ZINC3973334

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