Panacea Biotec, India's highly progressive research based pharmaceutical and biotechnology Company, announced that its 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 U.S. 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 USD 973.4 million and approximately USD 633.8 million in the US.

Panacea Biotec 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.

Rajesh Jain, Joint Managing Director, Panacea Biotec, said, "The FDA's acceptance of our ANDA filing is an important milestone for our 'Best-few' products development program and oncology portfolio as a whole. This ANDA filing acceptance gives us confidence in the strong understanding of science of developing such complex products at each level in the company, right from R&D to Operations, to ensure sustainable performance in years to come".

Shares of the company gained Rs 3.6, or 1.29%, to trade at Rs 283.55. The total volume of shares traded was 37,193 at the BSE (10.32 a.m., Thursday).