New Delhi: Aurobindo Pharma on Thursday said it has received approval from the US Food and Drug Administration (FDA) to market a generic version of Prilosec delayed-release capsules, used to treat ulcer, in the American market.
The company has received final approval from the US health regulator 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 ot June 30.
In a separate statement, the company said it has received approval from the US regulator to market a 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.
Shares in Aurobindo Pharma, on Thursday, ended over 2 per cent lower at Rs 798.45 apiece on the BSE.
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