Cipla gets USFDA nod for generic cancer drug

Drug major Cipla on Friday said it has received approval from the US health regulator to market a generic cancer treatment drug. The company has received the final approval from the US Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) submitted for paclitaxel protein-bound particles for injectable suspension (albumin-bound), 100 mg/vial, single-dose vial, Cipla said in a regulatory filing.

Cipla's protein-bound paclitaxel is a generic therapeutic equivalent version of Bristol Myers Squibb's Abraxane for injectable suspension 100 mg/vial.

Protein-bound paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas.


The product is expected to be launched in the first half of the current fiscal year in the US, the Mumbai-based drugmaker said.