Paclitaxel

Product manufactured by Hospira, Inc.

Application Nr Approved Date Route Status External Links
ANDA076131 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Paclitaxel Injection, Usp Is Indicated As Subsequent Therapy For The Treatment Of Advanced Carcinoma Of The Ovary. As First-Line Therapy, Paclitaxel Is Indicated In Combination With Cisplatin. Paclitaxel Is Indicated For The Adjuvant Treatment Of Node-Positive Breast Cancer Administered Sequentially To Standard Doxorubicin-Containing Combination Chemotherapy. In The Clinical Trial, There Was An Overall Favorable Effect On Disease-Free And Overall Survival In The Total Population Of Patients With Receptor-Positive And Receptor-Negative Tumors, But The Benefit Has Been Specifically Demonstrated By Available Data (Median Follow-Up 30 Months) Only In The Patients With Estrogen And Progesterone Receptornegative Tumors. (See Clinical Studies: Breast Carcinoma .) Paclitaxel Injection, Usp Is Indicated For The Treatment Of Breast Cancer After Failure Of Combination Chemotherapy For Metastatic Disease Or Relapse Within 6 Months Of Adjuvant Chemotherapy. Prior Therapy Should Have Included An Anthracycline Unless Clinically Contraindicated. Paclitaxel, In Combination With Cisplatin, Is Indicated For The First-Line Treatment Of Nonsmall Cell Lung Cancer In Patients Who Are Not Candidates For Potentially Curative Surgery And/or Radiation Therapy. Paclitaxel Is Indicated For The Second-Line Treatment Of Aids-Related Kaposi’s Sarcoma.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Paclitaxel PACLITAXEL ZINC96006020

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