Panacea Biotec gets USFDA nod for generic version of Abraxane
Panacea Biotec, India’s highly progressive research based pharmaceutical and biotechnology Company, announced that its abbreviated new drug application (ANDA) submitted under section S0S(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) for Paclitaxel Protein Bound Particles for injectable Suspension, l00mg/vial has been accepted for filing by the USFDA.
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 $973.4mn and approximately $633.8mn 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.
Dr.Rajesh Jain, Joint Managing Director 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 1n years to come”.
The stock is currently trading at Rs277.95, down by Rs9.1 or 3.17% from its previous closing of Rs287.05 on the BSE. The scrip opened at Rs283.7 and has touched a high and low of Rs294 and Rs275.95 respectively.
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Via:: Stock – India Infoline