New Delhi : Drug firm Aurobindo Pharma has received final approval from the USFDA to manufacture and market pantoprazole sodium for injections, used for the treatment of gastroesophageal reflux disease, in the American market.
“The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market pantoprazole sodium for injections, 40 mg/vial,” Aurobindo Pharma said in a BSE filing.
The firm said this product is expected to be launched in the first quarter of next fiscal.
The approved ANDA (Abbreviated New Drug Applications) is bioequivalent and therapeutically equivalent to the reference listed drug product Protonix I.V. for injection, 40 mg/vial for Wyeth Pharmaceuticals, it added.
According to IMS, the approved product has an estimated market size of USD 93.5 million for the twelve months ending February 2016, Aurobindo Pharma said.
Pantoprazole sodium for injections is a gastrointestinal drug used in the treatment of gastroesophageal reflux disease.
Aurobindo Pharma has a total of 249 ANDA approvals (213 final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from the US.
The shares of Aurobindo Pharma were trading 0.50 per cent down at Rs 738 apiece during afternoon session on BSE.