Aurobindo Pharma arm gets U.S. FDA nod for cancer drug copy
Drugmaker Aurobindo Pharma’s subsidiary Eugia Pharma Specialities has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market cancer drug Lenalidomide Capsules, in different strengths.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug, Revlimid Capsules, of Bristol-Myers Squibb Company. It is indicated for treatment of adult patients with multiple myeloma, in combination with Dexamethasone.
Aurobindo Pharma said the product is expected to be launched in October and it will be a volume specific launch.
This is the 155th abbreviated new drug application (ANDA), including nine tentative approvals received, out of Eugia Pharma Speciality Group facilities, manufacturing both oral and sterile specialty products, the company said.