New Delhi: Aurobindo Pharma has received final approval from the US health regulator to manufacture Esomeprazole Magnesium delayed-release capsules, used in the treatment of frequent heartburn, in the US market.
In a BSE filing, Aurobindo Pharma said it “has received final approval from the US Food and Drug Administration (USFDA) to manufacture Esomeprazole Magnesium Delayed-Release Capsules OTC, 20mg”.
The approved product is a therapeutically equivalent generic version of AstraZeneca’s Nexium 24HR capsules.
Aurobindo Pharma said the product will be launched immediately.
The company quoting IRI database said the approved product has an approximate annual sale 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.
Aurobindo now has a total of 335 ANDA approvals (296 final approvals including 16 from Aurolife Pharma LLC and 39 tentative approvals) from USFDA.