Aurobindo Pharma receives USFDA Approval for Ibandronate Sodium Tablets
Aurobindo Pharma Limited announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Ibandronate Sodium Tablets, 150 mg. This product is expected to be launched in Q1 FY16-17.
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The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Boniva® Tablets of Hoffman-La Roche Inc.
Ibandronate Sodium Tablets is used in the treatment and prevention of osteoporosis in postmenopausal women. The approved product has an estimated market size of US$ 55 million for the twelve months ending January 2016 according to IMS.
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This is the 65th ANDA (including 14 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 243 ANDA approvals (208 Final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.