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Multi-Dose Vial of Carboplatin Injection Gains Approval

SCHAUMBURG, Ill., Feb. 17 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (Nasdaq: APPX - News), today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carboplatin Injection (liquid form) in a 600 mg multi-dose vial. Carboplatin is the generic equivalent of Bristol-Myers Squibb Company's Paraplatin.

Combined sales of the 600 mg dosage form by all suppliers exceeded $18.5 million in 2005, according to IMS. American Pharmaceutical Partners (APP) expects to commence marketing the 600 mg vial in the near future.

"This approval is an important line extension to our portfolio of carboplatin products," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer of APP. "According to IMS, sales from all suppliers of the 600 mg multi-dose vials of carboplatin are increasing. The addition of this dosage form expands our strong and growing oncology portfolio and allows us to compete in a growing market with only two other suppliers of this particular presentation."

APP's carboplatin 600 mg is preservative-free and AP rated, and the product vials include a latex-free vial stopper, bar code and Tall Man Lettering label enhancements to help differentiate APP's carboplatin from other commonly used platinum-based chemotherapies with the same name suffix. APP also offers carboplatin in 450 mg (liquid and lyophilized), 150 mg (lyophilized) and 50 mg (lyophilized) vials.

Carboplatin is indicated for the initial treatment of advanced ovarian carcinoma in combination with other established approved chemotherapeutic agents, as well as for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy.

Source: American Pharmaceutical Partners, Inc.

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