The drug will be sold with the help of Canadian pharmaceutical distributor Apotex.
The annual sale of Abraxane worldwide is approximately US$973.4 million and approximately USS633.8 million in the US, the Indian company said.
The drug will be used for the treatment of Metastatic Breast Cancer, Non-Small Cell Lung Cancer and Adenocarcinoma of the Pancreas in the US.
The approved drug is Paclitaxel Protein Bound Particles in vials of 100mg.
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,” it 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,” said Rajesh Jain, Joint Managing Director, Panacea Biotec.
“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.”
Panacea Biotec is also amongst the top 15 pharmaceutical companies in its relevant markets in India and among top 60 top pharmaceutical companies in India overall.