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PharmaRoth Labs, Inc. Files New Dietary Ingredient Notification with the US Food and Drug Administration (FDA)
Date:3/26/2013

LAS VEGAS, Nev., March 26, 2013 /PRNewswire/ -- PharmaRoth Labs, Inc. (OTCPink: FROI) the exclusive producer, marketer & distributor of Sucanon®, an oral Type-II Diabetes treatment, proudly announced that the United States Food and Drug Administration (FDA) has received the Company's completed New Dietary Ingredient (NDI) Notification. The primary purpose of the NDI Notification process is to determine the safety of the main active ingredient(s), and it is required by the FDA as part of the process that products go through, in order to gain access to the U.S. markets. The company made the application through their Mexican subsidiary, Pharmaroth Latin America SA de CV. The Company has been diligently preparing the NDI notification application in consultation with Jeiven Pharmaceutical Consulting, Inc. of Scotch Plains, New Jersey.

"The filing of this application is a major milestone in the evolution of our product, Sucanon®," commented Luis Lopez , CEO of PharmaRoth. "Though the product is classified as a drug in some countries, in the U.S. it will be marketed as a dietary supplement because of the nature of its ingredients. The NDI designation is important to show the safety of our dietary ingredient, which has always been a hallmark of Sucanon®'s value. We are excited to be taking this step toward eventually bringing our remarkable product to the U.S."

PharmaRoth was aware of the significance of the NDI notification process, and engaged an industry-leading consulting firm, Jeiven Pharmaceutical Consulting, to assist with the NDA notification. "We are very fortunate to be working with the professionals at Jeiven. They are industry experts who have provided consulting services to company in FDA related matters involving pharmaceuticals, medical devices, and dietary supplement products and have been instrumental in this endeavor."


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SOURCE PharmaRoth Labs, Inc.
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