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Aurobindo Pharma gets USFDA nod for heartburn drug

Aurobindo Pharma said the product will be launched immediately

Press Trust of India  |  New Delhi 

drugs, medicines, USFDA

Pharma has received final approval from the US health regulator to manufacture Esomeprazole Magnesium delayed-release capsules, used in treatment of frequent heartburn, in the US market.

In a filing, Pharma said it "has received final approval from the (USFDA) to manufacture Esomeprazole Magnesium Delayed-Release Capsules OTC, 20mg".

The approved product is therapeutically equivalent generic version of AstraZeneca's Nexium 24HR capsules.

Pharma said the product will be launched immediately.

The company quoting IRI said the approved product has an approximate annual sales of USD 300 million.

This is the 127th Abbreviated New Drug Application (ANDA), including 23 tentative approvals, to be approved out of Unit VII formulation facility in Hyderabad, used for manufacturing oral products.

now has a total of 335 ANDA approvals (296 final approvals including 16 from Aurolife Pharma LLC and 39 tentative approvals) from

Stock of Pharma was trading 1.29 per cent higher at Rs 767.40 on

First Published: Tue, October 17 2017. 21:12 IST