Aurobindo Pharma gets USFDA nod to market ulcer drug

Indian pharma company Aurobindo Pharma on Thursday said it has received approval from the US health regulator 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 US Food and Drug Administration (USFDA) to manufacture and market Omeprazole delayed-release capsules in the strengths of 10mg, 20mg and 40mg, Aurobindo Pharma said in a statement.

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 $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.