Biocon Launches Psoriasis Drug In India; To File IND Application With US FDA This Fiscal

12 08 2013

New Drug Approvals

Kiran Mazumdar-Shaw
India’s Biocon on Saturday launched ALZUMAb, a novel biologic for the treatment of psoriasis, in India. Sreeja/IB Times
KIRAN MAZUMDAR SHAW,  CHAIRMAN BIOCON
itolizumab is other name
Jan 13: Biocon has received marketing approval in India. The company plans to file an investigational new drug application with the FDA seeking authorization for further human trials which will support regualtory approval in the US.
Biocon is to seek pre-IND advice from the US FDA .
On completing proof-of-concept PIII trials, Biocon will seek a licensing partner for itolizumab. The company has stated it expects to initiate licensing discussions during the 2010/2011 financial year

Bangalore, India-based Biocon (NSE:BIOCON) announced Saturday the launch of its first biologic drug for the treatment of chronic psoriasis in India, and said it would file an investigational new drug, or IND, application with the U.S. Food and Drug Administration, or FDA, by the end of this fiscal…

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