Panacea Biotec Ltd has announced that its abbreviated new drug application (ANDA) submitted under section 505(j) of the Federal Food, Drug and Cosmetic Act for paclitaxel protein bound particles for injectable suspension, 100mg/vial has been accepted for filing by the US Food and Drug Administration.
This product is a generic version of Abraxane, which is used for thetreatment of breast cancer, non-small lung cancer and adenocarcinoma of pancreas, it said.
“The FDA’s acceptance of our ANDA filing is an important milestone for our ‘Best-Few’ products development programme and oncology portfolio as a whole,” Panacea Biotec Joint Managing Director Rajesh Jain said.
Abraxane had an annual worldwide sales of approximately $973.4 million, and $633.8 million in the US, Panacea Biotec said citing Celgene Annual Report 2016.
The company shares ended lower by 3.17 per cent at Rs 277.95 on the BSE.