Aurobindo Pharma has got the USFDA final approval for manufacturing and marketing Esomeprazole Magnesium delayed release capsules that are used in the treatment of gastroesophageal reflux disease in the American market.
According to company, the launch of the product is based on the settlement terms/litigation outcome with AstraZeneca.
Aurobindo Pharma has said in a BSE filing that “The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Esomeprazole Magnesium delayed release capsules USP, 20mg and 40 mg.”
It further said that “The approved product has an estimated market size of USD 4.2 billion for the 12 months ended February 2016 according to IMS.”
