Ranbaxy gets USFDA approval for Ramipril capsules

Ranbaxy Laboratories has received an approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), to market and manufacture Ramipril capsules in dosages of 5 mg & 10 mg.

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, USFDA, had determined Ranbaxy’s formulation to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug, Altace manufactured 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 to reduce the risk of myocardial infarction, stroke or death from cardiovascular causes.