Ranbaxy Laboratories Limited has received an approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA), to market and manufacture ramipril capsules 5mg & 10mg.
The application for the drug was submitted by Ranbaxy from the Ohm Laboratories manufacturing facility, located in North Brunswick, New Jersey, USA. The Office of Generic Drugs, US FDA, had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug, Altace by King Pharmaceuticals Inc.
Ramipril is indicated in patients 55 years or older, who are at high risk of developing a major caridiovascular 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 myocardial infarction, 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).
"Ranbaxy is pleased to receive this final approval for Ramipril capsules. This is the third ANDA approval that materialized specific to Ohm Laboratories, in the last two months," said Jim Meehan, vice president, Sales & Distribution, RPI, USA.
Ohm, based in North Brunswick, New Jersey, USA, is a wholly-owned subsidiary of Ranbaxy Laboratories Limited. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.