US nod to Glenmark’s blood pressure drugJune 20th, 2008 - 5:09 pm ICT by IANS
Mumbai, June 20 (IANS) US drug authorities have given the green signal to Glenmark Pharmaceuticals to market and distribute the high blood pressure medicine, Trandolapril. According to a regulatory intimation issued Friday, the company said the approval for ANDA (abbreviated new drug application) from the US Food and Drug Administration (USFDA) was sought through Glenmark Generics Ltd (GGL), a subsidiary of Glenmark.
The company cited the quantum of the market for Trandolapril and stated that the high blood pressure drug had sales over $23 million, ending March 2008.
The recent approval coupled with the three other ANDA approvals by USFDA has brought GGL’s current portfolio of generic products authorised for the US market to 33. In addition to this, the company has over 35 ANDAs filed with USFDA, awaiting approval.
Tags: abbreviated new drug application, andas, authorities, awaiting approval, blood pressure drug, blood pressure medicine, food and drug, food and drug administration, generic products, generics, high blood pressure, intimation, medicine, pharmaceuticals, quantum, subsidiary, trandolapril, us food and drug administration, usfda