Synerx Pharma Announces Approval for Ciclopirox Topical 8% Solution.NEWTOWN, Pa. -- Synerx Pharma, LLC announced today that it has received final U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval for the Company's Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) for Ciclopirox topical solution, 8%. Synerx's product is a generic equivalent of Dermik Laboratories' prescription product Penlac[R], a topical ciclopirox treatment for nail fungus. Sales of Penlac[R] 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 USP - unique sales point . 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 Noun 1. privately held corporation - a corporation owned by a few people; shares have no public market close corporation, closed corporation, private corporation located in historic Bucks County, Pennsylvania Bucks County is a county located in the U.S. state of Pennsylvania. As of 2000, the population was 597,635. A 2004 U.S. Census estimate placed the population at 621,342, making it the fourth most populous county in Pennsylvania, after Philadelphia, Allegheny, and Montgomery . 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. |
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