Jun 8: Hyderabad-based drug maker Aurobindo Pharma Ltd on Friday announced that it has received the final approval from the US Food & Drug Administration (USFDA) to manufacture Omeprazole Delayed-Release tablets OTC, 20mg.
According to the company, the product is a generic equivalent of British-Swedish multinational drug manufacturer AstraZeneca’s Prilosec OTC tablets. The product will be launched in June 2018, it said.
“Omeprazole tablets are indicated for the treatment of frequent heartburn (occurs 2 or more days a week),” the company added.
The estimated market size of Prilosec OTC tablets is $ 222 million for the twelve months ending March 2018, according to Nielsen data.
This is Aurobindo’s 141st ANDA (including 20 tentative approvals) to be approved out of Unit VII formulation
facility in Hyderabad, India used for manufacturing oral products. The company now has a total of 369
ANDA approvals (336 Final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.