USFDA nod for Vyome Bio acne drug

Published Date: 14-01-2016 | 10:36 am

MUMBAI: Bio-pharmaceutical company Vyome Biosciences on Thursday said the US Food and Drug Administration (USFDA) has cleared its investigational new drug (IND) to treat moderate-to-severe acne.

“We have received USFDA acceptance of Investigational New Drug application in the US for our lead product VB-1953 to treat moderate-to-severe acne. We plan to start Phase-I clinical trials very soon,” a company statement said here.

“With US FDA accepting our first IND application for the lead program VB-1953, we have become a clinical stage company in US, which is an important value inflection milestone for us. “This should pave way for further filings with the USFDA in future,” chief executive N Venkat said. “VB-1953 is a first-in-class new product in Acne therapy for addressing one of the very important and a large unmet need.” —PTI

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