Application Nr Approved Date Route Status External Links
ANDA207934 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Everolimus Tablets Is A Kinase Inhibitor Indicated For The Treatment Of: Postmenopausal Women With Advanced Hormone Receptor-Positive, Her2-Negative Breast Cancer In Combination With Exemestane After Failure Of Treatment With Letrozole Or Anastrozole. ( 1.1 ) Adults With Progressive Neuroendocrine Tumors Of Pancreatic Origin (Pnet) Limitation Of Use : Everolimus Tablets Is Not Indicated For The Treatment Of Patients With Functional Carcinoid Tumors. ( 1.2 ) Adults With Advanced Renal Cell Carcinoma (Rcc) After Failure Of Treatment With Sunitinib Or Sorafenib. ( 1.3 ) Adults With Renal Angiomyolipoma And Tuberous Sclerosis Complex (Tsc), Not Requiring Immediate Surgery. ( 1.4 ) Everolimus Tablets Are Kinase Inhibitors Indicated For The Treatment Of Adult And Pediatric Patients Aged 1 Year And Older With Tsc Who Have Subependymal Giant Cell Astrocytoma (Sega) That Requires Therapeutic Intervention But Cannot Be Curatively Resected. ( 1.5 ) 1.1 Hormone Receptor-Positive, Her2-Negative Breast Cancer (Advanced Hr+ Bc) Everolimus Tablets Are Indicated For The Treatment Of Postmenopausal Women With Advanced Hormone Receptor-Positive, Her2-Negative Breast Cancer In Combination With Exemestane, After Failure Of Treatment With Letrozole Or Anastrozole. 1.2 Neuroendocrine Tumors (Net) Pancreatic Neuroendocrine Tumors (Pnet) Everolimus Tablets Are Indicated For The Treatment Of Adult Patients With Progressive Neuroendocrine Tumors Of Pancreatic Origin (Pnet) With Unresectable, Locally Advanced Or Metastatic Disease. Limitation Of Use : Everolimus Tablets Are Not Indicated For The Treatment Of Patients With Functional Carcinoid Tumors [See Clinical Studies ( 14.2 )]. 1.3 Renal Cell Carcinoma (Rcc) Everolimus Tablets Are Indicated For The Treatment Of Adult Patients With Advanced Rcc After Failure Of Treatment With Sunitinib Or Sorafenib. 1.4 Tuberous Sclerosis Complex (Tsc)-Associated Renal Angiomyolipoma Everolimus Tablets Are Indicated For The Treatment Of Adult Patients With Renal Angiomyolipoma And Tsc, Not Requiring Immediate Surgery. 1.5 Tuberous Sclerosis Complex (Tsc)-Associated Subependymal Giant Cell Astrocytoma (Sega) Everolimus Tablets Are Indicated In Adult And Pediatric Patients Aged 1 Year And Older With Tsc For The Treatment Of Sega That Requires Therapeutic Intervention But Cannot Be Curatively Resected.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Everolimus

Comments