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news.The US Food and Drug Administration (FDA) has published final approval of Itonis Pharmaceuticals' National Drug Code (NDC) number (59067-001) for its Emesyl over-the-counter (OTC) homeopathic product for nausea relief.
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Additionally, the company had recently received a Notice of Allowance from the US Patent & Trademark Office for its Emesyl trademark.
The NDC number and trademark Notice of Allowance has allowed Itonis to enter the final stage of its product packaging design, and the production of Emesyl will soon start with its manufacturer, Oasis Health Products.
Itonis will market Emesyl to national retailers, including drugstore retailers, department stores, cruiselines, and other strategic retail sectors upon receiving its first production batch from Oasis.
Emesyl and the Zicam Cold Remedy inventor Charles Hensley said reaching these significant NDC and trademark milestones required a lot of hard work and patience.
"We have wasted no time in prompting our manufacturer to finalize all steps for the first production run of Emesyl, bringing us one step closer to market," Hensley said.
According to a report by a British research company Visiongain, the worldwide market for OTC drugs could exceed $70bn by 2015.