USFDA approves Aurobindo’s heartburn drug

Image credit- consumerreports.org

Aurobindo Pharma has received final approval from the US health regulator to manufacture Omeprazole delayed-release tablets OTC, 20mg, used in the treatment of frequent heartburn. The approved product is a generic equivalent of AstraZeneca's Prilosec tablets.

Omeprazole tablets are indicated for the treatment of frequent heartburn (occurring two or more days a week).

This is the 141st ANDA (abbreviated new drug application), including 20 tentative approvals, to be approved out of unit VII formulation facility in Hyderabad used for manufacturing oral products.

According to Aurobindo Pharma, the estimated market size of Prilosec OTC tablets is $222 million for the twelve months ending March 2018.