Ajanta Pharma gets USFDA Nod for Generic Acid Reflux Drug

July 29, 2016

US health regulator has given nod for Ajanta Pharma for generic Omeprazole and sodium bicarbonate powder for oral suspension used for treatment of stomach and esophagus problems such as ulcers and acid reflux.

The company has received approval from the United States Food and Drug Administration (USFDA) for the same and will soon be launching the product, Ajanta Pharma said in a BSE filing.

The launch will be in two strengths, 20 mg/1680 mg and 40 mg /1680 mg powder sachets, it added.The product is generic version of Santarus INC’s Zegerid powder for oral suspension, Ajanta Pharma said.

This new approval is part of portfolio of products that the company has developed for the US market, it added. In total, it has 26 Abbreviated New Drug Application (ANDA) of which it has final approvals for 12 ANDAs, tentative approvals for 1 ANDA and 13 ANDAs are under review with USFDA, Ajanta Pharma said.