LAS VEGAS, NV -- (Marketwired) -- 03/17/14 -- PharmaRoth Labs, Inc. (OTC Pink: ROTH) (PINKSHEETS: ROTH) the exclusive producer, marketer & distributor of Sucanon®, an oral Type-II Diabetes treatment, announced today the FDA's response concerning the Company's New Dietary Ingredient (NDI) Application, filed last March. The Company's treatment is derived from natural ingredients, which generally allows it to be considered a nutraceutical product. However, upon careful review, the FDA determined that the active ingredient in Sucanon® will not be classified under a nutraceutical designation, but will henceforth be considered an Investigational New Drug (IND).
Due to the IND status of Sucanon®, PharmaRoth would have to go through the FDA's IND process before the product would be available for US distribution. "We are very satisfied with the FDA's determination, as we have always felt that Sucanon® was a drug," stated Luis Lopez, CEO of PharmaRoth. "Now that the FDA agrees with our findings, it is actually a very positive thing for the product going forward: a 'drug' designation by the US FDA has large beneficial implications on a international level. The fact that Sucanon® is powerful enough to be considered a drug will make the product more acceptable in many countries."
For further information regarding Sucanon®, please visit PharmaRoth Labs, Inc. website at www.pharmaroth.com
PharmaRoth Labs, Inc. (OTC Pink: ROTH) (PINKSHEETS: ROTH) 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.
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