Cipla receives US FDA approval for generic version of Abraxane
Cipla secures final USFDA approval for Protein-bound Paclitaxel 100 mg/vial; launch planned in H1 FY26 in the US market
Cipla has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial, Single-Dose Vial.
The announcement was made pursuant to Regulation 30 read with Schedule III Part A Para B of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and the SEBI circular dated 11 November 2024.
Cipla’s Protein-bound Paclitaxel is an AB-rated generic therapeutic equivalent of Bristol Myers Squibb’s Abraxane for Injectable Suspension 100 mg/vial. The product 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 approval was granted on 10 April 2025, and the product is expected to be launched in the United States in the first half of the financial year 2025–26.
The company has stated that this approval represents a step forward in expanding its oncology portfolio in regulated markets.