Aurobindo Pharma receives USFDA approval for gastro reflux drug
Drug firm Aurobindo Pharma has received final approval from USFDA to manufacture and market Esomeprazole Magnesium delayed release capsules, used in a 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, 20 mg and 40 mg," Aurobindo Pharma said in a Bombay Stock Exchange (BSE) filing.
The approved abbreviated new drug application (ANDA) is a bio-equivalent and therapeutically equivalent to the reference listed drug product Nexium delayed-release capsules USP, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals, it added.
"The approved product has an estimated market size of $4.2 billion (nearly Rs 27,941.6 crore) for the 12 months ended February 2016, according to IMS," it said.
Esomeprazole Magnesium delayed-release capsules is used in a treatment of gastroesophageal reflux disease.
Aurobindo Pharma currently has a total of 253 ANDA approvals -- 217 final approvals including 10 from Aurolife Pharma LLC and 36 tentative -- from the USFDA.
At 13:32 hours, on Friday, the shares of Aurobindo Pharma were trading up 2.40% or Rs 18.45 at Rs 786.10 per scrip on the BSE.