The US Food and Drug Administration (USFDA) has approved Indian drug firm, Aurobindo Pharma, to manufacture and market its generic version of Eli Lilly's Evista tablets used to treat and prevent osteoporosis in postmenopausal women.
The approval by the USFDA for Raloxifene Hydrochloride tablets is for strength of 60 mg, which is bio and therapeutically equivalent to the reference listed drug product (RLD) Evista, 60 mg of Eli Lilly, the company said in a statement.
The product has an estimated market size of USD 404 million for the 12 months ended June 2015, the company added, citing IMS data. This is the 45th Abbreviated New Drug Application (ANDA) to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products.
Aurobindo now has a total of 210 ANDA approvals, 182 final ones, including 9 from Aurolife Pharma LLC and 28 tentative approvals from US FDA, it added.