Cipla gets USFDA nod for Paclitaxel Protein bound Particles for Injectable Suspension
Mumbai: Cipla has announced that the Company 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 10th 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.
Read also: Cipla gets exclusive rights to market ophthalmic drug across 11 countries
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets. It has strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments. It has 47 manufacturing sites around the world which produces 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to its 80+ markets.
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