Ranbaxy Laboratories Limited has received approval from the FDA for its abbreviated new drug application to market and manufacture Ramipril 5-mg and 10-mg capsules.
The application for the drug was submitted by Ranbaxy from the Ohm Laboratories manufacturing facility, located in North Brunswick, N.J. The Office of Generic Drugs at FDA had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug Altace (ramipiril) by King Pharmaceuticals.
The Gurgaon, India-based company said Ramipril is indicated in patients 55 years or older, who are at high risk of developing a major cardiovascular event or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertensive, elevated total cholesterol levels, low HDL levels, cigarette smoking or documented microalbuminuria) to reduce the risk of MI, stroke or death from cardiovascular causes. Ramipril can be used in addition, to other needed treatment, such as anti-hypertensive, antiplatelet or lipid lowering therapy.