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Mayne Pharma (USA) Inc.

U.S. FDA approves packaging for multi-dose generic Carboplatin

Published in Biotech Law Weekly, August 26th, 2005

Mayne Pharma (USA) Inc. announced that on June 10 it received approval for its labels, cartons and package inserts to reflect multi-dose labeling on Carboplatin 50mg/5mL, 150mg/15mL, 450mg/45mL and 600mg/60mL solution presentations.

Mayne has only generic Carboplatin 600 mg/60mL multi dose solution presentation. Carboplatin is an alkylating agent used to treat ovarian cancer and other cancers.

All newly manufactured product will be labeled with multi-dose labels. In the meantime, any existing vials with the single dose label will be considered as multi-dose products by the Centers for Medicaid and Medicare Services (CMS).

Mayne's...

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