LAS VEGAS, NV--(Marketwired - Mar 17, 2014) - 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.
Forward Looking Statements: Statements in this document contain certain 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, as amended. These statements are based on many assumptions and estimates and are not guarantees of future performance. These statements may involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of PharmaRoth Labs, Inc. to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. PharmaRoth Labs, Inc. assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors. There may be other factors not mentioned above that may cause actual results to differ materially from those projected in any forward-looking statement. We assume no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by applicable securities laws.