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news.Mayne Pharma (USA), part of Mayne Group, has launched the first generic version of a carboplatin 600mg/60ml injection, the generic equivalent of Bristol-Myers Squibb's ovarian cancer treatment, Paraplatin.
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The FDA granted approval for Mayne’s abbreviated new drug application (ANDA) for carboplatin 600mg/60ml solution in November 2004. Carboplatin is used for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents, and the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy.
Mayne Pharma now has carboplatin injection available in 50mg/5ml, 150mg/15ml, 450mg/45ml and 600mg/60ml presentations.
“Mayne is excited to be able to offer the first generic alternative of the 600mg solution presentation to our customers. This is an important addition for our customers and enables us to offer the full range of Carboplatin presentations,” Stuart Hinchen, Mayne Pharma’s president of the Americas, said.
The product incorporates Onco-Tain technology, a sheath around both solution and lyophilized cytotoxics that gives extra strength to the vial, reducing breakage and enhancing pharmacy safety.