Navigation Links
PharmaRoth Labs, Inc. Files New Dietary Ingredient Notification with the US Food and Drug Administration (FDA)

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."

About Sucanon®

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

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.

For investor relations contact:

Michael Irving 
Paramount Advisors, LLC
(407) 878-5462

SOURCE PharmaRoth Labs, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Fero Industries, Inc. Changes Name to PharmaRoth Labs, Inc.
2. Zacks Industry Outlook Highlights: Eli Lilly, Forest Labs, ViroPharma, Novartis and United Therapeutics
3. Ameritox Files Amended Complaint Against Millennium Laboratories For Injunctive Relief, Declaratory Relief and Damages
4. WuXi PharmaTech Files 2011 Annual Report on Form 20-F
5. Mindray Files Annual Report on Form 20-F with the U.S. Securities and Exchange Commission
6. ShangPharma Corporation Files 2011 Annual Report on Form 20-F
7. Sunpeaks Ventures Files Defamation Lawsuit
8. Everett Laboratories, Inc. Files Patent Infringement Lawsuit Against Competitor Trigen Laboratories, Inc.
9. SIGA Technologies Files Notice of Appeal in PharmAthene Litigation
10. DataMotion Files Provisional Patent for Technology that Enables Easy and Secure Doctor-Patient Email Interaction
11. Sanford Wittels & Heisler Files $100 Million Gender Discrimination Class Action In Southern District Of New York
Post Your Comments:
(Date:6/23/2016)... , June 23, 2016 Research ... Devices Global Market - Forecast to 2022" report to ... the treatment method for the patients with kidney failure, it ... excess fluid from the patient,s blood and thus the treatment ... potassium and chloride in balance. Increasing number ...
(Date:6/23/2016)... June 23, 2016  In a startling report released today, ... residents by lacking a comprehensive, proven plan to eliminate prescription opioid ... ranking of how states are tackling the worst drug crisis in ... states – Kentucky , New Mexico ... . Of the 28 failing states, three – ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... ... recently awarded their highest five-star rating to Best Buy Eyeglasses, an ... United States and Canada wear eyeglasses. Once considered to be a purely functional part ... fashion statement. Even celebrities use glasses as a way of creating an iconic image—like ...
(Date:6/26/2016)... Battle Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... abuse, joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table ... held in honor of the city’s history as home to some of the world’s ...
(Date:6/26/2016)... ... 2016 , ... PawPaws brand pet supplements owned by Whole Health ... the health of felines. The formula is all-natural and is made from Chinese herbs ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
Breaking Medicine News(10 mins):