Cipla gets USFDA’s final approval for generic cancer drug

11 Apr 2025 Evaluate

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 for Injectable Suspension (albumin-bound), 100 mg/vial, Single-Dose Vial (‘Protein-bound Paclitaxel’) on April 10, 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.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients.


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