India’s Ajanta gets green light for its high blood pressure generic
November 2, 2016Ajanta 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.