Aurobindo Pharma has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Raloxifene Hydrochloride tablets.
The approved drug is bio-equivalent and therapeutic equivalent to the reference listed drug product (RLD) Evista tablets of Eli Lilly.
Raloxifene Hydrochloride are indicated for treatment and prevention of osteoporosis in post-menopausal women.
The product had an estimated market size of $404 million for the twelve months ending June 2015 according to IMS.
This is the 45th abbreviated new drug application (ANDA) to be approved out of Unit VII formulation facility of Aurobindo in Hyderabad for manufacturing oral non-antibiotic products. The Hyderabad-based firm now has a total of 210 ANDA approvals (182 final approvals including nine from Aurolife Pharma LLC and 28 tentative approvals) from USFDA, according to a release issued here on Saturday.
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