PharmaRoth Labs, Inc. Files New Dietary Ingredient Notification with the US Food and Drug Administration (FDA)
Company Takes Important Step Toward Sucanon®’s Entry Into the US Market
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.”
Sucanon(®) is a dietary supplement containing natural ingredient. In certain ex-US countries, it is one of only three approved drugs in the multi-billion dollar market for a class of diabetic medications called “insulin sensitizers”. Pre-clinical and clinical studies conducted ex-US have shown that Sucanon(®) and other insulin sensitizers lower a patient’s blood sugar by increasing the muscle, fat and liver’s sensitivity to the body’s own naturally produced insulin. Sucanon(®) has been approved for prescription sale in China and Peru. Sucanon(®) is also approved as an OTC treatment for Type-II diabetes by regulatory authorities in Mexico. Sucanon(®) will be marketed as a dietary supplement in the US.
For further information regarding Sucanon(®), please visit PharmaRoth Labs, Inc. website at www.feroindustries.com.
About PharmaRoth Labs, Inc.
PharmaRoth Labs, Inc. (OTCPink: FROI) is focused on diabetes prevention and treatments. The Company holds the intellectual property and all exclusive world-wide rights related to the production, marketing, and distribution of Sucanon(®), an oral treatment for Type-II diabetes. Sucanon(®) is a member of a class of diabetic medications called insulin sensitizers. Insulin sensitizers lower blood sugar by increasing the muscle, fat and liver’s sensitivity to insulin. Insulin sensitizers are blood sugar normalizing or euglycemic drugs that help return the blood sugar to the normal range without the risk of low blood sugars. PharmaRoth’s strategy is to increase awareness, acceptance, and distribution of Sucanon(®) globally.
About Jeiven Pharmaceutical Consulting, Inc.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE PharmaRoth Labs, Inc.