Aurobindo Pharma has received final approval from the US health regulator to manufacture Omeprazole delayed-release tablets, used in the treatment of frequent heartburn. The approved product is a generic equivalent of AstraZeneca’s Prilosec tablets.
“The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Omeprazole delayed-release tablets OTC, 20mg. The product will be launched in June 2018,” Aurobindo Pharma said in a BSE filing today.
Omeprazole tablets are indicated for the treatment of frequent heartburn (occurring two or more days a week).Quoting Nielsen data, Aurobindo Pharma said the estimated market size of Prilosec OTC tablets stood at $222 million for the 12 months ended March 2018.
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, the company said.
Aurobindo now has 369 ANDA approvals (336 final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA. The company shares were trading 2.88 per cent higher at Rs 563.50 on the BSE.