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news.American Pharmaceutical Partners has received approval from the FDA to begin marketing carboplatin injection in a 600mg multi-dose vial.
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Carboplatin is a generic version of Bristol-Myers Squibb’s ovarian cancer treatment, Paraplatin. Combined sales of the 600mg dosage form by all suppliers exceeded $18.5 million in 2005, the company said.
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.
“This approval is an important line extension to our portfolio of carboplatin products,” said Dr Patrick Soon-Shiong, chairman, president and CEO of APP. “According to IMS, sales from all suppliers of the 600mg multi-dose vials of carboplatin are increasing.”