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30-Nov2017

Panacea Biotec gets acceptance for ANDA for Paclitaxel Protein Bound Particles by USFDA

Panacea Biotec's abbreviated new drug application (ANDA) submitted under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) for Paclitaxel Protein Bound Particles for injectable Suspension, 100mg/vial has been accepted for filing by the US Food and Drug Administration (FDA).

This product is the generic version of Abraxane, marketed for the treatment of Metastatic Breast Cancer, Non-Small Cell Lung Cancer and Adenocarcinoma of the Pancreas in the US market. The annual sale of Abraxane worldwide is approximately $973.4 million and approximately $633.8 million in the US.

The company has already commercialized this product in India and emerging markets like Sri Lanka, Turkey etc. under the trademark - PacliALL. The company looks forward to commercializing this product in US and several other markets worldwide in collaboration with Apotex.

Panacea Biotec is a leading biotechnology company with established research, manufacturing and marketing capabilities. It is one of the largest vaccine producers and leading Biotechnology Companies in India.


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