Aurobindo gets US FDA nod for gastrointestinal drug

This product is expected to be launched in the first quarter of FY17

Aurobindo Pharma Limited announced today that the company has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Pantoprazole Sodium for injection, 40 mg/single dose vial. This product is expected to be launched in the first quarter of the year 2016-17.

The approved abbreviated new drug application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product Protonix of Wyeth Pharmaceuticals, Inc. The product is a gastrointestinal drug used in the treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, in adults.

Read more from our special coverage on "AUROBINDO PHARMA"

• Aurobindo Pharma gets final USFDA nod for gastro reflux drug
• Aurobindo Pharma gets USFDA nod for antibiotic drug
• Aurobindo Pharma gets FDA nod for Alzheimers, Parkinsons drug
• Aurobindo Pharma gains on USFDA nod for Naproxen Sodium Tablets
• Aurobindo Pharma gets final nod for osteoporosis drug

The approved product has an estimated market size of $93.5 million for the twelve months ending February, 2016, according to a company statement