Application Nr Approved Date Route Status External Links
ANDA204406 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Topotecan Injection Is Indicated For The Treatment Of: Small Cell Lung Cancer Sensitive Disease After Failure Of First-Line Chemotherapy. In Clinical Studies Submitted To Support Approval, Sensitive Disease Was Defined As Disease Responding To Chemotherapy But Subsequently Progressing At Least 60 Days (In The Phase 3 Study) Or At Least 90 Days (In The Phase 2 Studies) After Chemotherapy [See Clinical Studies ( 14 ) ] . Topotecan Injection In Combination With Cisplatin Is Indicated For The Treatment Of: Stage Iv-B, Recurrent, Or Persistent Carcinoma Of The Cervix Which Is Not Amenable To Curative Treatment With Surgery And/or Radiation Therapy. Topotecan Is A Topoisomerase Inhibitor Indicated For: Small Cell Lung Cancer Sensitive Disease After Failure Of First-Line Chemotherapy. ( 1 ) Combination Therapy With Cisplatin For Stage Iv-B, Recurrent, Or Persistent Carcinoma Of The Cervix Which Is Not Amenable To Curative Treatment With Surgery And/or Radiation Therapy. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Topotecan TOPOTECAN ZINC1611274

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