Sun Pharmaceutical Industries Ltd has received USFDA approval for the Abbreviated New Drug Application (ANDA) to market generic Paraplatin Æ, carboplatin injection, the company informed the Bombay Stock Exchange.
These generic versions of carboplatin 10mg/ml injections packed in 5 ml, 15ml and 45 ml single use vials are bioequivalent to Paraplatin Æ 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 ParaplatinÆ Injections have annual sales of approximately $45 million in the US.
Paraplatin Æ is a registered trademark of Bristol Myers Squibb Company.