Glenmark Pharma seeks US approval for its new drugApril 10th, 2008 - 6:43 pm ICT by admin
Mumbai, April 10 (IANS) Pharma major Glenmark Pharmaceuticals Ltd has sought approval from the US Food and Drug Administration (USFDA) to carry out clinical studies of its drugs prescribed in the treatment of pulmonary and bowel diseases. The company said in a statement here Thursday it has carried out an investigation new drug (IND) application. Pre-clinical studies and research have proved the success of the new medical approach, which involves monoclonal antibody GBR 500 (group B rotavirus).
Glenmark, after embarking on the clinical tests, intends to file an IND application with the USFDA for Phase I test by August 2008 and a Phase II test thereafter.
The primary aim is to develop GBR 500 for symptoms of diseases such as Multiple Sclerosis (MS) Chronic Obstructive Pulmonary Disease (COPD) and Inflammatory Bowels Disease (IBD).
According to the communiqu
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