Cipla Limited has announced a significant milestone with the 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. The approval, granted on April 10, 2025, clears the way for Cipla to market a generic version of Bristol Myers Squibb’s Abraxane® in the United States.
Cipla’s AB-rated generic is a therapeutic equivalent to Abraxane®, a widely used chemotherapy drug. It 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.
This approval strengthens Cipla’s oncology portfolio and reinforces its commitment to providing high-quality, affordable medicines in the U.S. market. The company plans to launch the product in H1 FY 2025-26, expanding access to critical cancer treatment options.
