USFDA approves Marketing of Aurobindo Pharma’s Ulcer Drug
The US Food and Drug Administration (USFDA) has approved Aurobindo Pharma to market generic version of Prilosec delayed-release capsules used to treat ulcer.
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The company has received final approval from the USFDA to manufacture and market Omeprazole delayed-release capsules in the strengths of 10mg, 20mg and 40mg, Aurobindo Pharma said.
The company's approved abbreviated new drug application (ANDA) is a generic version of AstraZeneca Pharmaceuticals' Prilosec capsules, it added. Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults.
In a separate statement, the company said it has received approval from the USFDA to market generic version of Hoffmann-La Roche's Boniva injection in the American market.The company's Ibandronate Sodium injection is indicated for the treatment of osteoporosis in postmenopausal women.
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