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Cancer Therapy

Sicor announces tentative ANDA approval for carboplatin injection

Published in Women's Health Weekly, October 3rd, 2002

Sicor Inc., (SCRI) announced that the Food and Drug Administration (FDA) has tentatively approved an abbreviated new drug application (ANDA) by its wholly owned subsidiary, Gensia Sicor Pharmaceuticals, Inc., for Carboplatin Injection.

Carboplatin is indicated for the treatment of patients with ovarian cancer. Gensia Sicor's carboplatin product is a liquid ready-to-use formulation packaged in a shatter resistant polymer vial.

Based on data from IMS Health, a market research firm, U.S. sales of carboplatin in 2001 were approximately $470 million. The branded product, Paraplatin, is marketed by Bristol-Myers Squibb.

Sicor, Inc.,...

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