Cipla Gets US FDA Nod For Generic Abraxane

Cipla said it has received final approval from the US Food and Drug Administration for its abbreviated new drug application for protein-bound Paclitaxel. The injectable, at 100 mg per vial for single-dose use, was approved on Thursday, the company said in a filing.

The drug is an AB-rated generic equivalent of Bristol Myers Squibb’s Abraxane, used in the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer, and metastatic pancreatic adenocarcinoma.

Cipla said it plans to launch the product in the US market in the first half of 2025-26.