Aurobindo Pharma receives USFDA approval for Ibandronate Sodium Injection and Omeprazole

Aurobindo Pharma Ltd has received approval from the US Food & Drug Administration (USFDA) to manufacture and market Ibandronate Sodium Injection used in treatment of osteoporosis in postmenopausal women. It is bioequivalent and therapeutically equivalent to Boniva Injection of Hoffmann-La Roche, Inc. which is the reference listed drug product (RLD)

The company also received final approval from the USFDA to manufacture and market Omeprazole Delayed-release Capsules. 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.

Company Profile : Aurobindo Pharma Ltd

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