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Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Ibandronate Sodium Injection.
It is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Boniva Injection of Hoffmann-La Roche, Inc. Ibandronate Sodium Injection is indicated for the treatment of osteoporosis in postmenopausal women.
Aurobindo has also received final approval from the USFDA to manufacture and market Omeprazole Delayed-release Capsules.
It is bioequivalent and therapeutically equivalent to the reference listed drug product Prilosec Delayed-release Capsules of AstraZeneca Pharmaceuticals.
The tablets are indicated for short-term treatment of active duodenal ulcer in adults. The product has an estimated market size of $422 million for the 12 months ended June 30, 2015, according to IMS.
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