Cipla receives USFDA approval for Protein-bound Paclitaxel for Injectable Suspension

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

Cipla has received final approval from the United States Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) submitted for Paclitaxel Protein-bound Particles forInjectable Suspension (albumin-bound), 100 mg/vial, Single-Dose Vial (Protein-bound Paclitaxel) on 10th April, 2025.

Cipla’s Protein-bound Paclitaxel is an AB-rated 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 (NSCLC) and metastatic adenocarcinoma of the pancreas. The product is expected to be launched in H1 FY 2025-26 in the United States of America.