Itonis Pharmaceuticals in Final Steps of NDC Registration With FDA for Emesyl Product
Posted 12:01:00 04/22/2014 by Admin
LAGUNA HILLS, CA (Marketwired Apr 22, 2014) Itonis, Inc. (PINKSHEETS: ITNS) is pleased to share an update from its manufacturer that the Company's Emesyl™ anti-nausea product is in its final steps of completing the NDC registration with the Food and Drug Administration (FDA), and is being readied for the first production run. While the process has taken longer than expected, the Company is pleased with recent progress to deliver Emesyl™ to market.
The manufacturer's CEO said, "We are in the final steps of helping Itonis get the [Emesyl™] product NDC registered with the FDA, and doing the final sourcing of the key unique ingredients we need to get a production run up on our filling line."
The complete update from the Emesyl™ manufacturer Oasis Health Products is available at http://www.itonisholdings.com/data/supporting_files/uploads/15363e20eae63f-dk_letter_to_mark_cheung_april_21_2014.pdf
"We are excited that the Company will be clearing this final governmental hurdle for the National Drug Code number that will enable the final labeling of the Emesyl™ product. An NDC number is a universal product identifier that is required for all drug products whether pharmaceutical or homeopathic," says Mark Cheung, Itonis' CEO.
About Itonis Pharmaceuticals
Itonis Pharmaceuticals, a division of Itonis, Inc., is headed by Charles Hensley, Ph.D., and its mission is to create and market over-the-counter and prescription homeopathic products that better people's lives. Dr. Hensley is a pioneer in the development and marketing of safe and effective therapeutic nutraceutical and homeopathic preparations. He was a founder of the company that launched the Zicam(R) Cold Remedy, making the product a household name and forever changing the marketing and product placement paradigm for homeopathic drugs in the United States. Dr. Hensley and his team plan to use the same methodologies to revolutionize the treatment of several other common ailments and other chronic diseases.
About Itonis, Inc.
Itonis, Inc. was incorporated in the state of Nevada on July 5, 2005 under the name of Kenshou, Inc., which later changed to Itonis, Inc. on December 2, 2005. Please visit www.itonisholdings.com.
Statements in this press release may constitute forward-looking statements and are subject to numerous risks and uncertainties, including the failure to complete successfully the development of new or enhanced products, the Company's future capital needs, the lack of market demand for any new or enhanced products the Company may develop, any actions by the Company's affiliates that may be adverse to the Company, the success of competitive products, other economic factors affecting the Company and its markets, seasonal changes, and other risks detailed from time to time in the Company's filings with the U.S. Securities and Exchange Commission. The actual results may differ materially from those contained in this press release. The Company disclaims any obligation to update any statements in this press release.
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