Navigation Links
PharmaRoth Labs, Inc. Files New Dietary Ingredient Notification with the US Food and Drug Administration (FDA)
Date:3/26/2013

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 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.

www.jeiven.com

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:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... 12, 2017   Divoti USA will engrave ... the standard of the latest FDA requirements, which stipulates new criteria ... Anyone in need of Medical ID jewelry such as Medical ID ... are engraved in terms of the new FDA requirements . ... Divoti offers this dark mark ...
(Date:10/11/2017)... FRISCO, Texas , Oct. 11, 2017 /PRNewswire/ ... healthcare services, has amplified its effort during National ... patients about hereditary cancer risks. ... Journal of Clinical Oncology calculated that more than ... to have inherited mutations in BRCA1 or BRCA2 and ...
(Date:10/7/2017)... , Oct. 6, 2017   Provista, a ... than $100 billion in purchasing power, today announced a ... information. The Newsroom is the online home ... trends, infographics, expert bios, news releases, slideshows and events. ... to a wealth of resources at their fingertips, viewers ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... While it’s often important to take certain medications during the night, finding them ... a solution. , She developed a prototype for MOTION LIGHT-UP PILL BOX to provide ... need to turn on a light when taking medication during the night, allowing the ...
(Date:10/13/2017)... QUEENS, N.Y (PRWEB) , ... October 13, 2017 , ... ... recently became a member of ElderCounsel, a national organization of elder law and special ... constantly changing laws and rules. It also provides a forum to network with elder ...
(Date:10/13/2017)... ... 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at ... towards children of all ages; it is a non-competitive, non-timed event, which is all ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “America On ... Christian identity. “America On The Brink” is the creation of published author, William ... several great-grandchildren. As a WWII veteran, he spent thirty years in the Navy. ...
(Date:10/12/2017)... PALM CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... of cold therapy products, announced today the introduction of an innovative new design of ... the multipurpose pad so you get maximum comfort while controlling your pain while using ...
Breaking Medicine News(10 mins):