Sun Pharma gets US approval for Paraplatin injectionSeptember 23rd, 2008 - 9:32 pm ICT by IANS
New Delhi, Sep 23 (IANS) Sun Pharmaceutical Industries Ltd Tuesday said it has got the US Food and Drug Administration (USFDA) approval for the abbreviated new drug application (ANDA) to market generic Paraplatin, a carboplatin injection.These generic versions of carboplatin 10 mg/ml injections, packed in 5 ml, 15 ml and 45 ml single use vials, are bio-equivalent to Paraplatin injections distributed by Bristol Myers Squibb Oncology/Virology, a patient assistance program provided by Bristol Myers Squibb Co.
The injections are mainly utilised during initial and secondary therapy in patients with advanced ovarian carcinoma.
These strengths of Paraplatin injections have annual sales of approximately $45 million in the US.
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Tags: abbreviated new drug application, bristol myers squibb, bristol myers squibb co, food and drug administration, ovarian carcinoma, paraplatin, patient assistance program, sun pharma, sun pharmaceutical industries, us food and drug administration