New Delhi: Aurobindo Pharma said it 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.
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 is USD 222 million for the twelve months ending 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 a total of 369 ANDA approvals (336 final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.