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MUMBAI, India — Glenmark Pharmaceuticals Inc. USA has received final approval from the Food & Drug Administration for raloxifene hydrochloride tablet.
Glenmark said Wednesday that its raloxifene product is a generic equivalent of Evista tablets (60 mg) from Eli Lilly and Co.
Raloxifene, which reduces the loss of bone tissue, is indicated for the treatment or prevention of osteoporosis in postmenopausal women. The medication also is used to lower the risk of invasive breast cancer in postmenopausal women who have osteoporosis or are otherwise at risk of invasive breast cancer.
Branded and generic versions of raloxifene totaled sales of approximately $336.5 million for the 12-month period ending in January, according to IMS Health data reported by Glenmark.
