Ajanta Pharma has gotten US FDA’s approval to launch its high blood pressure tablets Amlodipine in the US through its local subsidiary Ajanta Pharma USA.
Amlodipine+Olmesartan Medoxomil tablets are bioequivalent generic version of Daiichi Sankyo’s Azor.
Ajanta has gotten the green light to launch the tablet in four strenghts, 5+20mg, 5+40mg, 10+20mg, and 10+40mg.
This is Ajanta’s 29th Abbreivated New Drug Application, of which it has 16 final approvals, 2 tentative approvals, and 11 ANDAs that the US FDA is still reviewing.