New Delhi: Panacea Biotec has announced that its abbreviated new drug application (ANDA) for paclitaxel protein-bound particles for injectable suspension, l00mg/vial has been accepted for filing by the United States Food and Drug Administration (US-FDA). The company had earlier submitted the application under section S0S(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act).
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.
In his comments on the latest development, Dr Rajesh Jain, Joint Managing Director mentioned, “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”.