New Delhi : Drug firm Aurobindo Pharma has received final approval from USFDA to manufacture and market Esomeprazole Magnesium delayed release capsules, used in treatment of gastroesophageal reflux disease, in the American market.
The company said the launch of the product is based on the settlement terms/litigation outcome with AstraZeneca.
“The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Esomeprazole Magnesium delayed release capsules USP, 20mg and 40 mg,” Aurobindo Pharma said in a BSE filing.
The approved abbreviated new drug application (ANDA) is bio equivalent and therapeutically equivalent to the reference listed drug product Nexium delayed release capsules USP, 20mg and 40 mg, of AstraZeneca Pharmaceuticals, it added.
“The approved product has an estimated market size of USD 4.2 billion for the 12 months ended February 2016, according to IMS,” it said.
Esomeprazole Magnesium delayed release capsules is used in treatment of gastroesophageal reflux disease.
This is the 70th ANDA (including 15 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 253 ANDA approvals (217 Final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.