Cipla’s abbreviated new drug application for a generic version of Bristol Myers Squibb’s cancer drug Abraxane has received final approval from the U.S. Food and Drug Administration.
The final approval for Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial, single-dose vial was received on April 10. It is an AB-rated generic therapeutic equivalent version of Bristol Myers Squibb’s Abraxane for Injectable Suspension 100 mg/vial. Cipla expects to launched the product in the U.S. by September.
Protein-bound Paclitaxel is indicated for treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas, Cipla said on Friday.
Published – April 11, 2025 09:32 pm IST