FDA Approves ANDA 076235 for Carboplatin Injection (Fresenius Kabi USA)

On October 14, 2004 the U.S. Food and Drug Administration issued an approval (submission number 1, status "AP") for ANDA 076235 covering carboplatin injection products. The sponsor, Fresenius Kabi USA, submitted the application which included three injectable strengths of carboplatin: 50 mg/vial, 150 mg/vial, and 450 mg/vial. Each product is listed with a marketing status of "Discontinued". The approval letter and related documentation are available through the FDA’s public database (http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76235ltr.pdf).