India First Edition

Sun Pharmaceutical gets USFDA approval for Paraplatin injection

Mumbai, September 23, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted an approval for the Abbreviated New Drug Application (ANDA) to market generic Paraplatin ®, carboplatin injection.
These generic versions of carboplatin 10mg/ml injections packed in 5 ml, 15ml and 45 ml single use vials are bio-equivalent to Paraplatin ® injections distributed by Bristol Myers Squibb Oncology/Virology.
Carboplatin injections are indicated as initial and secondary therapy in patients with advanced ovarian carcinoma.
These strengths of Paraplatin® Injections have annual sales of approximately USD 45 million in the US.