Aurobindo Pharma gets USFDA nod for two generics

August 20, 2015 04:56 pm | Updated March 29, 2016 04:23 pm IST - Hyderabad:

Hyderabad-based Aurobindo Pharma has got US Food & Drug Administration (USFDA) approval for manufacturing and marketing Ibandronate Sodium injection and Omeprazole Delayed-release capsules.

The Ibandronate Sodium injection is indicated for treatment of osteoporosis in postmenopausal women. It is bio-equivalent and therapeutically equivalent to the reference listed product (RLP), Boniva of Hoffmann-La Roche. With this, Aurobindo Pharma has 14 abbreviated new drug application (ANDAs) approved out of its Unit-IV formulation facility in Hyderabad for manufacturing general injectable products, a release from the company said.

Omeprazole Delayed-release capsules, used in short-term treatment of active duodenal ulcer in adults, is bio-equivalent and therapeutically equivalent to the RLP, Prilosec Delayed-release capsules of AstraZeneca Pharmaceuticals. The product had an estimated market size of $422 million in the 12 months ended June 2015.

This is the 43rd ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing Oral Non-betalactam products. Aurobindo now has a total of 208 ANDA approvals from USFDA, the company said.

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