USFDA11 Apr 2025, 01:57 pm
Cipla Receives USFDA Approval for ANDA of Paclitaxel Protein-bound Particles
AI Summary
Cipla Ltd has announced that it has received final approval from the USFDA for the ANDA submitted for Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial, Single-Dose Vial. The product, an AB-rated generic therapeutic equivalent version of Bristol Myers Squibb’s Abraxane® for Injectable Suspension 100 mg/vial, is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic 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.
Key Highlights
- Cipla receives final approval from USFDA for Paclitaxel Protein-bound Particles for Injectable Suspension
- The product is an AB-rated generic therapeutic equivalent version of Bristol Myers Squibb’s Abraxane® for Injectable Suspension 100 mg/vial
- Indicated for the treatment of metastatic breast cancer, locally advanced or metastatic NSCLC, and metastatic adenocarcinoma of the pancreas
- Expected to be launched in H1 FY 2025-26 in the United States of America