FDA News

Novel Files First ANDA Application with the FDA

(Aug 23, 2007)-- Novel Laboratories, LLC, the generic drug joint venture company formed by VGS Pharma, LLC and Elite Pharmaceuticals, announced the filing of Novel's first Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA).

Novel Laboratories is a specialty pharmaceutical company focusing on the development and manufacturing of generic pharmaceuticals with high barriers to entry. The company is headed by CEO Veerappan Subramanian, Ph.D., an industry veteran. Dr. Subramanian was the founder and Chief Executive Officer of Kali Laboratories, Inc., a specialty generic pharmaceutical company, which was acquired by Par Pharmaceuticals in 2004. Prior to founding Kali Labs, Veerappan was Vice President of Scientific Affairs at Zenith Laboratories from 1990 until 1996.

Dr. Subramanian stated, "We are pleased to have filed our first ANDA and have achieved this milestone within nine months after Novel's formation in December 2006. Novel currently has a robust generic product pipeline under development and we look forward to filing additional ANDA's before year end."

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