Aurobindo Pharma receives US FDA approval for Omeprazole delayed-release capsules

Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults

Aurobindo Pharma has received the final approval from the US Food & Drug Administration (US FDA) to manufacture and market Omeprazole delayed-release capsules USP, 10 mg, 20 mg and 40 mg (ANDA 203270). The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Prilosec delayed-release capsules, 10 mg, 20 mg and 40 mg of AstraZeneca Pharmaceuticals.

Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. The product has an estimated market size of $ 422 million for the twelve months ending June 2015 according to IMS. This is the 43rd ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing oral non-betalactam products. Aurobindo now has a total of 208 ANDA approvals (180 final approvals including nine from Aurolife Pharma LLC and 28 Tentative approvals) from US FDA.