CHERRY HILL, N.J.--(BUSINESS WIRE)--Nuvilex, Inc. (OTC Bulletin Board: NVLX - News), announces today that Legacy Biotechnologies, Inc., its joint venture partner in Reme-Flu™, has received its National Drug Code numbers (50107-100-00, 50107-200-00, and 50107-300-00), from the Food and Drug Administration (FDA) for its homeopathic flu remedy. A National Drug Code (NDC) is a universal identifier of any product that is to be marketed as a drug for human use within the United States. The Drug Listing Act of 1972 states that all registered drug establishments must provide to the FDA a current list of all drugs manufactured, prepared, propagated, compounded, or processed by the establishment for commercial distribution.
As a registered homeopathic medicine, Reme-Flu™ is intended for use at the onset of flu or flu-like symptoms and contains ingredients widely recognized to reduce and/or shorten flu or flu-like symptoms. Legacy Biotechnologies’ Syn-X9™ formulation enhances the body’s utilization of Reme-Flu's™ active ingredients.
With the issuance of the NDC for Reme-Flu™, Legacy Biotechnologies is now preparing to manufacture, market and sell Reme-Flu™ for the spring 2010 flu season. Further details on Legacy’s marketing plans will be forthcoming.
“Legacy Biotechnologies has undertaken the appropriate and necessary steps to register Reme-Flu™ with the FDA insuring that Reme-Flu™, its labeling and packaging meet FDA standards for homeopathic remedies,” stated Martin Schmieg, Chairman and CEO of Nuvilex, Inc. “The registration process for Reme-Flu™ was exacting and time consuming, but was necessary in order to ensure that Reme-Flu™ could legally enter the marketplace. We greatly appreciate Legacy Biotechnologies’ building, registering and launching Reme-Flu™ with a commitment to quality, performance and customer satisfaction.”
According to the FDA Code of Federal Regulations, registration of a drug establishment or drug wholesaler, or assignments of a registration number, or assignment of an NDC number, does not in any way denote approval of the firm or its products.
About Nuvilex, Inc.
Nuvilex, Inc. is an emerging healthcare consumer products company. The Company’s lead products include: Cinnergen™, which promotes a healthy glucose metabolism; Cinnechol™, designed to help maintain normal cholesterol levels and support normal cardiovascular function; and Infinitink®, a permanent yet more easily removable tattoo ink. The Company’s complete portfolio spans aesthetics, dermatology, environmental and nutraceutical products, all of which are designed to directly or indirectly improve human health. In March 2009, Nuvilex merged with Freedom2 Holdings, Inc., the developer of Infinitink®. In conjunction with the merger, the Company changed its name to Nuvilex, Inc. from eFoodSafety.com. Please visit http://www.nuvilex.com/ for additional information on the Company.
About Legacy Biotechnologies, Inc.
Legacy Biotechnologies, Inc. is an independent, privately-owned firm specializing in the research and development of nutriceutical and cosmeceutical formulations. They specialize in creating innovative and cutting-edge compounds that address all facets of health. Its president, Steve Kushner, has been working in this field for over 26 years and has created several original formulas that have been marketed both on a national basis and abroad. Mr. Kushner's experience allows Legacy Biotechnologies, Inc. to excel at all phases of the health and nutrition industry. In addition to research and development, Legacy Biotechnologies, Inc. is also well-versed in the manufacturing process, procurement of raw materials, creation of promotional material, and marketing of products.
Safe Harbor Statement
Statements contained in this presentation that are not strictly historical are "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934. The forward-looking statements are made based on information available as of the date hereof, and the Company assumes no obligation to update such forward-looking statements. Forward-looking statements are sometimes identified by words such as "intends", "anticipates", "believes", "expects", and "hopes" and involve a number of risks and uncertainties that could cause the Company's actual results to differ materially from projected results. All parties are cautioned that such forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from those in these forward-looking statements. Such risks and uncertainties include but are not limited to demand for the Company's products and services, the planned share exchange with Freedom2 Holdings, Inc., our ability to secure additional financing, and other factors that may be more fully described in reports to shareholders and periodic filings with the Securities and Exchange Commission.
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