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Sun Pharmaceutical wins FDA approval for cancer drug’s ANDA

Sun Pharmaceutical Industries has announced that FDA has granted an approval for the abbreviated new drug application to market generic Paraplatin, carboplatin injection.

These generic versions of carboplatin 10mg/ml injections packed in 5ml, 15ml and 45ml single use vials are bioequivalent 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.