Synerx Pharma Announces Approval for Ciclopirox Topical 8% Solution

NEWTOWN, Pa.--(BUSINESS WIRE)--Synerx Pharma, LLC announced today that it has received final U.S. Food and Drug Administration (FDA) approval for the Company’s Abbreviated New Drug Application (ANDA) for Ciclopirox topical solution, 8%. Synerx’s product is a generic equivalent of Dermik Laboratories’ prescription product Penlac®, a topical ciclopirox treatment for nail fungus. Sales of Penlac® in the U.S. exceeded $85 million in 2006.

Synerx Pharma currently has ten products under various stages of development, in addition to its presently approved and marketed Testosterone Cypionate Injection, USP. Synerx’s development efforts encompass four different dosage form categories and five exclusive Active Pharmaceutical Ingredient agreements with multiple manufacturers. The Company achieved its goal of filing 5 ANDA’s with FDA by the close of 2006, and anticipates filing an additional two to three ANDA’s by the close of 2007.

About Synerx Pharma, LLC:

Synerx Pharma LLC is a privately held corporation located in historic Bucks County, Pennsylvania. Established in January 2004, the company focuses primarily on cost-effective specialty generic products aimed at meeting underserved consumer needs, particularly those involving some combination of barriers to entry.

Synerx Pharma commercializes its products through the aggressive establishment of development, manufacturing, and supply partnerships bringing quality, value-added products to the marketplace. Synerx partners with high quality contract development and manufacturing organizations, leveraging their diverse capabilities in a variety of dosage forms and delivery technologies.

Synerx Pharma welcomes inquiries concerning partnership opportunities. Inquiries from companies outside the U.S. regarding the commercialization of their products and technologies in the U.S. marketplace are also encouraged.