PharmaRoth Labs, Inc. Announces Results From FDA Application
March 17 2014 - 8:45AM
Marketwired
PharmaRoth Labs, Inc. Announces Results From FDA Application
FDA Determines Company's Proprietary Diabetes Product Cannot Be
Classified as Nutraceutical, Sucanon(R) Now Considered a Drug
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
About PharmaRoth
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.
For investor relations contact: Michael Irving Paramount
Advisors, LLC (407) 878-5462
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