Cipla receives USFDA approval for Paclitaxel injectable suspension

Cipla (BSE:CIPLA) announced today that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) concerning Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial, Single-Dose Vial ("Protein-bound Paclitaxel"). This product is an AB-rated generic therapeutic equivalent to Bristol Myers Squibb's Abraxane and 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. Cipla anticipates launching the product in the first half of fiscal year 2025-26 in the United States. The announcement was made in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.