The US Food and Drug Administration (USFDA) has approved Aurobindo Pharma to market generic version of Prilosec delayed-release capsules, used to treat ulcer, in the American market.
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.
According to IMS, the product had an estimated market size of USD 422 million for the twelve months ended June 30.
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.