New Delhi: Panacea Biotec said the US health regulator has accepted its filing for approval of generic version of cancer treatment injection Abraxane.
The company’s abbreviated new drug application (ANDA) for Paclitaxel Protein bound particles for injectable suspension, 100mg/vial has been accepted for filing by the US Food and Drug Administration (USFDA), Panacea Biotec said in a BSE filing.
This product is a generic version of Abraxane, which is used for the treatment of breast cancer, non-small lung cancer and adenocarcinoma of the 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 sale of approximately USD 973.4 million, and USD 633.8 million in the US, Panacea Biotec said citing Celgene Annual Report 2016.