Aurobindo receives FDA approval for ulcer drug
21 August 2015 | News | By BioSpectrum Bureau
Aurobindo receives FDA approval for ulcer drug
The drug is approved in the strengths of 10mg, 20mg and 40mg
Aurobindo Pharma has announced that the company has received the final approval from the US Food and Drug Administration (US FDA) to manufacture and market Omeprazole Delayed-release Capsules USP, 10mg, 20mg and 40mg (ANDA 203270).
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Prilosec Delayed-release Capsules, 10mg, 20mg and 40mg 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.
