Carboplatin

Product manufactured by Hospira, Inc.

Application Nr Approved Date Route Status External Links
ANDA076517 2004-10-14 Intravenous RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications Initial Treatment Of Advanced Ovarian Carcinoma Carboplatin Injection Is Indicated For The Initial Treatment Of Advanced Ovarian Carcinoma In Established Combination With Other Approved Chemotherapeutic Agents. One Established Combination Regimen Consists Of Carboplatin Injection And Cyclophosphamide. Two Randomized Controlled Studies Conducted By The Ncic And Swog With Carboplatin Versus Cisplatin, Both In Combination With Cyclophosphamide, Have Demonstrated Equivalent Overall Survival Between The Two Groups (see Clinical Studies ). There Is Limited Statistical Power To Demonstrate Equivalence In Overall Pathologic Complete Response Rates And Long-Term Survival (≥ 3 Years) Because Of The Small Number Of Patients With These Outcomes: The Small Number Of Patients With Residual Tumor <2 Cm After Initial Surgery Also Limits The Statistical Power To Demonstrate Equivalence In This Subgroup. Secondary Treatment Of Advanced Ovarian Carcinoma Carboplatin Injection Is Indicated For The Palliative Treatment Of Patients With Ovarian Carcinoma Recurrent After Prior Chemotherapy, Including Patients Who Have Been Previously Treated With Cisplatin. Within The Group Of Patients Previously Treated With Cisplatin, Those Who Have Developed Progressive Disease While Receiving Cisplatin Therapy May Have A Decreased Response Rate.

All Formulated Excipients (1 Total)

Name Structure Kind Function Status
1. Acetone ACETONE Molecular SOLV-Solvent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Carboplatin

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