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

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 10 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.

 

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