The US Food and Drug Administration (FDA) has granted final approval to Ajanta Pharma’s omeprazole and sodium bicarbonate powder for oral suspension - a heartburn drug, which helps reduce the amount of acid produced by the cells in the stomach.
The approved product, which is a bioequivalent generic version of Salix Pharmaceuticals’ Zegerid powder, will be launched in two strengths 20 mg / 1680 mg and 40 mg / 1680 mg powder sachets.
This new approval is part of an ever growing portfolio of products that Ajanta has developed for the US market. In total, Ajanta 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 US FDA.