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Aurobindo Pharma has got the final approval from USFDA for manufacturing and marketing Ibandronate Sodium tablets that are used in the treatment and prevention of osteoporosis in women, in the American market.
Aurobindo Pharma has said in a BSE filing that “The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Ibandronate Sodium Tablets, 150 mg.”
According to the company this product is expected to be launched in the first quarter of next fiscal.
It further added that the approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Boniva Tablets of Hoffman-La Roche Inc.
