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Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Raloxifene Hydrochloride tablets.
The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Evista tablets of Eli Lilly.
Raloxifene Hydrochloride tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. The product has an estimated market size of $404 million for the 12 months ended June 30, 2015, according to IMS.
This is the 45th Abbreviated New Drug Application to be approved out of Unit VII formulation facility of Aurobindo in Hyderabad for manufacturing oral non-antibiotic products.
The Hyderabad-based firm has 210 ANDA approvals (182 final approvals, including 9 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA, according to a release issued here on Saturday.
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