Aurobindo Pharma has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Raloxifene Hydrochloride Tablets USP 60mg (ANDA 204310). The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Evista Tablets, 60mg of Eli Lilly.
Raloxifene Hydrochloride Tablets are indicated for treatment and prevention of osteoporosis in postmenopausal women. The product has an estimated market size of $404 million for the twelve months ending June 2015.
This is the 45th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 210 ANDA approvals (182 Final approvals including 9 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.
