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."


'/>"/>

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

Page: 1 2 3

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:4/28/2015)... N.J. , April 28, 2015 As ... Stryker Orthopaedics, is kicking off tournament week by heading ... second consecutive year appearing at the tournament, Stryker continues ... about the importance of joint health and mobility. As ... , Stryker is bringing new features to enhance ...
(Date:4/28/2015)... April 28, 2015   HX360 today ... of the inaugural HX360 Innovation Challenge ... improved patient experience in hospital and health system ... original field of eighty-three entries, with the four ... panel during the HX360 Innovation Challenge program at ...
(Date:4/28/2015)... -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP ) ... I am very excited to announce that we ... clinical trial for oral insulin (ORMD-0801) and the treatment of ... in the coming weeks. This clinical trial will be our largest ... milestone for the company, literally putting us in a different ...
Breaking Medicine Technology:The Stryker Mobility Zone Heads to Insperity Invitational for Second Consecutive Year 2The Stryker Mobility Zone Heads to Insperity Invitational for Second Consecutive Year 3The Stryker Mobility Zone Heads to Insperity Invitational for Second Consecutive Year 4Ginger.io And WiserCare Named Winners Of The HX360 Innovation Challenge 2Ginger.io And WiserCare Named Winners Of The HX360 Innovation Challenge 3Oramed Pharmaceuticals Inc. Issues Phase IIb Study Update Letter 2Oramed Pharmaceuticals Inc. Issues Phase IIb Study Update Letter 3
... Aug. 2 Cytokine PharmaSciences,Inc. (CPSI) today ... inhibitors showed oral efficacy in animal models. ... it is advancing one of these compounds,into ... or MIF, is linked to many,conditions, including ...
... ARBOR, Mich., Aug. 3 Far more of today,s,heart attack ... clogged heart arteries than even a,decade ago, a new study ... from this urgent treatment,-- which is known to save lives ... it at all, the study shows. And the chance ...
Cached Medicine Technology:Cytokine Demonstrates Oral Efficacy of Small-Molecule MIF Inhibitors 2Many Heart Attack Patients Don't Get Best Emergency Treatment 2Many Heart Attack Patients Don't Get Best Emergency Treatment 3Many Heart Attack Patients Don't Get Best Emergency Treatment 4
(Date:4/28/2015)... 28, 2015 OsteoRemedies®, LLC, Memphis, ... two-stage revision of infected hip and knee arthroplasty. ... as a pre-formed, pre-loaded spacer with Gentamicin Antibiotics, ... joint space. Combined with a consistent process ... spacer is approved for temporary use for up ...
(Date:4/28/2015)... CA (PRWEB) April 28, 2015 Once considered ... Grow Lights have taken the industry by storm with perfectly ... to use unit. , More than half of ... KIND LED , proving the stigma is gone and ... The overwhelming positive response from customers and their first hand ...
(Date:4/28/2015)... 2015 Jovium®, a brand focused on ... better emotional balance, has begun to increase its market ... scale to enhance their mood and relieve some of ... Jovium® System aims to help patients overcome some of ... through all-natural products that do not cause or carry ...
(Date:4/28/2015)... NV (PRWEB) April 28, 2015 According ... Center for Ethics (June 27, 2014), prescription drugs ... world. Medical Science is becoming increasingly aware of the ... the market, such as chemotherapy drugs to treat cancer, ... that are quickly evolving to become increasingly resistant to ...
(Date:4/28/2015)... Foot and Ankle Specialists of ... Palmer ( Annapolis and Clarksville Divisions ) was ... the Maryland Podiatric Medical Association meeting on April 15, ... in 1992 with a Bachelor of Arts in Life ... intercollegiate soccer, track and cross-country. He then attended the ...
Breaking Medicine News(10 mins):Health News:SuperCloset Reports Surge in KIND LED Grow Light Sales, Saving Indoor Growing Enthusiasts up to 40% on their Power Usage. 2Health News:Jovium® Products Help Customers to Achieve Emotional Balance 2Health News:Trivedi Science™ Announces the Beginning of Their Science Research to Create Highly Effective Pharmaceutical Drugs with Minimal Side Effects 2Health News:Trivedi Science™ Announces the Beginning of Their Science Research to Create Highly Effective Pharmaceutical Drugs with Minimal Side Effects 3Health News:Trivedi Science™ Announces the Beginning of Their Science Research to Create Highly Effective Pharmaceutical Drugs with Minimal Side Effects 4Health News:Foot and Ankle Specialists of the Mid-Atlantic, LLC Podiatrist Receives Maryland Podiatric Medical Association Outstanding Service Award 2
... , , CUPERTINO, Calif., July ... that Matthew Hogan, Chief Financial Officer, will be presenting at the ... August 5 at 4:00 pm Eastern Time. The conference is ... A webcast of the presentation will be accessible at: ...
... , WASHINGTON, July 28 The ... House of Representatives, goal of expanding health coverage to a ... the Society urges the House to make significant revisions to ... care its first priority and protect patient access to specialists. ...
... FRANKLIN LAKES, N.J., July 28 The Board of Directors ... a quarterly dividend of 33 cents per common share, payable on September ... annual dividend rate is $1.32 per share. , , ... technology company that develops, manufactures and sells medical devices, instrument systems and ...
... , MORRISTOWN, N.J., July 28 Watson Pharmaceuticals, ... and specialty branded pharmaceuticals, today announced a license agreement with ... generic version of Ferrlecit (sodium ferric gluconate complex in sucrose ... anemia in hemodialysis patients receiving supplemental epoetin therapy. , ...
... , , Hoag Hospital recognized ... providing optimal level care to breastfeeding mothers and infants , ... Memorial Hospital Presbyterian announced today its designation as a certified Baby-Friendly ... World Health Organization (WHO) and the United Nations Children,s Fund (UNICEF). ...
... PHILADELPHIA Cancer researchers are turning to mathematical models ... paper in Cancer Research , a journal of ... technique may answer questions about Herceptin resistance. ... Oncology Program at the University of Michigan Comprehensive Cancer ...
Cached Medicine News:Health News:DURECT to Present at the BMO Capital Markets Healthcare Conference 2Health News:SCAI Opposes U.S. House of Representatives Health Reform Bill in Current Form 2Health News:SCAI Opposes U.S. House of Representatives Health Reform Bill in Current Form 3Health News:Watson Announces License Agreement With GeneraMedix for Generic Version of Ferrlecit(R) 2Health News:Hoag Hospital Certified as Baby-Friendly Facility 2Health News:Hoag Hospital Certified as Baby-Friendly Facility 3Health News:Mathematical modeling predicts response to Herceptin 2
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: