Navigation Links
Paratek Pharmaceuticals Announces Expanded FDA Grant of Qualified Infectious Disease Product (QIDP) Designation for Its Lead Product Candidate, Omadacycline
Date:5/1/2013

BOSTON, May 1, 2013 /PRNewswire-iReach/ -- Paratek Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's lead antibiotic candidate, omadacycline, as a Qualified Infectious Disease Product (QIDP) for the treatment of complicated Urinary Tract Infections (cUTI).  This QIDP designation is applicable for both intravenous (IV) and oral formulations of omadacycline.

The QIDP designation provides Paratek access to certain incentives, including priority review associated with a New Drug Application (NDA) submission, eligibility for fast-track status for smaller population studies targeting certain resistant organisms, and a five-year extension of exclusivity under the Hatch-Waxman Act upon FDA approval of omadacycline. This designation is in addition to that announced by Paratek on January 3, 2013 granting QIDP status for IV and oral formulations of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

The QIDP designation, which the Company believes is a first for an orally available antibiotic for the treatment of cUTI, is provided under the Generating Antibiotic Incentives Now Act (GAIN Act), which was enacted in July 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), formerly known as Prescription Drug User Fee Act V (PDUFA V).  Experts have noted that there is a serious unmet need for new oral antibiotics to treat multi-drug resistant (MDR) bacteria such as E. coli that occur in cUTI and other infections.  In studies conducted to date, omadacycline achieves high concentrations in the urinary tract following oral dosing and retains activity against MDR E. coli and other bacteria common to community-acquired cUTI.  Paratek plans to conduct a cUTI Phase 2 clinical study with omadacycline.  '/>"/>

SOURCE Paratek Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. GW Pharmaceuticals Announces Pricing of Initial Public Offering on the NASDAQ Global Market
2. Tolero Pharmaceuticals announces Worldwide Agreement with Sanofi for the In-license of Alvocidib (Flavopiridol)
3. Avanir Pharmaceuticals Announces Date of Fiscal 2013 Second Quarter Financial Results and Conference Call
4. Catabasis Pharmaceuticals Announces Issuance of Patents for CAT-1000 and CAT-2000 Series
5. Selexis SA Sells Rights to Royalty Payments for More Than 15 Biologic Development Programs to Ligand Pharmaceuticals
6. Oramed Pharmaceuticals to Present Results of its Key Clinical Studies of Oral Insulin in Type 1 Diabetes Patients at the GTC Diabetes Summit, Boston, MA; April 29-30, 2013
7. Auxilium Pharmaceuticals Completes Acquisition Of Actient Holdings LLC To Create A Leading Urology Franchise With A Diversified Product Portfolio And Strong Growth Profile
8. Absorption Pharmaceuticals to Receive Patent for Premature Ejaculation Topical Medication
9. Novartis Pharmaceuticals Corporation disputes allegations in two US Government lawsuits and looks forward to a fair discussion of the facts
10. Arena Pharmaceuticals to Host Corporate Update and Financial Results Conference Call and Webcast on Thursday, May 2
11. Avanir Pharmaceuticals Receives Positive CHMP Opinion for Approval of NUEDEXTA in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/17/2014)... 2014 ... the addition of the  "China Interventional Cardiovascular ...      (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ... China impacted by accelerated ... concept, dietary habit, way of working and ...
(Date:10/17/2014)... , October 17, 2014 ... Imaging Market by Technique (Optical Coherence Tomography, ... software) & by Application (Ophthalmology, Neurology, Oncology, Cardiology) - ... report studies the Optical Imaging market over ... was valued at $917.1 million in 2014 ...
(Date:10/17/2014)... 17, 2014 A victim of medical negligence at ... doctor with a history of alcohol abuse, a physician and ... Prop 46 today, highlighting how Prop 46 will identify and ... The ad pictures a doctor drinking at ... ER."  Proposition 46 will enact the first law in the ...
Breaking Medicine Technology:China Interventional Cardiovascular Device Industry Report 2014-2017 2China Interventional Cardiovascular Device Industry Report 2014-2017 3Optical Imaging Market Worth $1,669.2 Million by 2019 2Optical Imaging Market Worth $1,669.2 Million by 2019 3Optical Imaging Market Worth $1,669.2 Million by 2019 4Victim Of Negligence At Hands Of A Drunk Doctor, A Physician and Consumer Advocates Release New Yes on 46 TV Ad, "On Call" 2Victim Of Negligence At Hands Of A Drunk Doctor, A Physician and Consumer Advocates Release New Yes on 46 TV Ad, "On Call" 3Victim Of Negligence At Hands Of A Drunk Doctor, A Physician and Consumer Advocates Release New Yes on 46 TV Ad, "On Call" 4
(Date:10/20/2014)... The Advocator Group, LLC is proud ... for Suicide Prevention’s (AFSP) Out of the Darkness walk ... that hosts hundreds of community walks throughout the country ... to help understand and prevent suicide through not only ... , The Advocator Group shares this passion for ...
(Date:10/20/2014)... Women’s health specialist, Dr. Amber Murphy, MD, Ob/Gyn ... Inc., A Division of MaternOhio Clinical Associates, Inc., who ... patients annually. Dr. Murphy will provide a full range ... women’s life. She is accepting new patients at two ... , Dr. Murphy offers a wide variety of services ...
(Date:10/20/2014)... Indianapolis, IN (PRWEB) October 20, 2014 ... Quick Start, a secure cloud solution that enables ... advantage of the ultimate healthcare-specific customer relationship management ... to meet the unique needs of the healthcare ... healthcare experience for providers and patients by combining ...
(Date:10/20/2014)... JZ Fitness, an independently operated wellness ... programming, authorship, international lecturing and community wellness, created by ... release of the JZ Fitness nutrition app, available on ... thousands of individuals on nutrition, Jenn Zerling (“JZ”) has ... require calorie counting or cumbersome food logging. ...
(Date:10/20/2014)... Ohio (PRWEB) October 20, 2014 Principle ... years, takes pride in manufacturing top-of-the-line absorbent products. ... image of its most popular brand, Tranquility® Premium Protection ... created a new website, gave its packaging a new ... bring the brand message to the public. , The ...
Breaking Medicine News(10 mins):Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 2Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 3Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 2Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 3Health News:Healthcare Relationship Management (HRM) Leader hc1.com® Launches hc1® Quick Start™ 2Health News:JZ Fitness Nutrition App Launches on iTunes 2Health News:JZ Fitness Nutrition App Launches on iTunes 3Health News:Tranquility® Premium Protection Incontinence Products Releases New Logo and Website 2
... 104 vehicles provide basic healthcare for residents ... of remote areas of Andhra Pradesh,- Innovative healthcare ... Management Research ... Ltd. (NYSE: SAY ), a leading global consulting and information,technology ...
... 26 Particle Sciences Inc. today,announced the ... of drug-eluting polymer medical devices that release ... more. This technology has already been used,by ... rings. "Drug release,from polymeric materials often follows ...
... the Medical Imaging Contrast Agent Association (MICAA), the Council on ... Association (AMIA), will host Medical Imaging Continuum: Path Forward for ... New Biopharmaceutical Products (October 2-3; Bethesda, MD) ... ...
... Industry Leader in Generic Market Information Offers Single Authoritative, ... ... Generics and API Manufacturers, JAKARTA, Indonesia, Aug. 26 /Xinhua-PRNewswire/ ... in,competitive advantage from launch of two solutions in the market ...
... 25 AtriCure, Inc.,(Nasdaq: ATRC ), a medical ... today announced that it will present at the following,investor ... Healthcare Conference at the Four Seasons,Hotel in Boston on ... Executive Officer, is scheduled to present at 10:55,a.m. Eastern ...
... 25 HCA marked its 40th,anniversary during a special ... The event featured HCA Co-Founder and Chairman Emeritus, Dr. ... Bovender, Jr., who spoke about,HCA,s founding, mission and tradition ... "Our History of Caring" program was a,prelude to HCA,s ...
Cached Medicine News:Health News:Satyam Launches Comprehensive, Mobile Healthcare Program for Rural Indians 2Health News:Satyam Launches Comprehensive, Mobile Healthcare Program for Rural Indians 3Health News:Satyam Launches Comprehensive, Mobile Healthcare Program for Rural Indians 4Health News:Satyam Launches Comprehensive, Mobile Healthcare Program for Rural Indians 5Health News:Particle Sciences Develops Zero-Order-Release Combination Device Technology 2Health News:Shaping Best Practices For Standardized Medical Imaging In Clinical Trials 2Health News:Shaping Best Practices For Standardized Medical Imaging In Clinical Trials 3Health News:Indonesia's Pharmaceutical companies Get Boost in Competitive Advantage from Launch of Newport Horizon Premium and IDRAC Solutions by Thomson Reuters 2Health News:Indonesia's Pharmaceutical companies Get Boost in Competitive Advantage from Launch of Newport Horizon Premium and IDRAC Solutions by Thomson Reuters 3Health News:AtriCure to Participate at the Thomas Weisel Partners Healthcare Conference and the UBS Global Life Sciences Conference in September 2Health News:HCA Celebrates 40th Anniversary 2
... Signature Series multipurpose gamma camera is designed ... The system uniquely combines the high-energy and ... flexibility of modern day SPECT and planar ... maximizes camera performance in PET ...
Sharp diamond shaped double blade in stainless steel....
... AXIOM Artis TA is part ... dynamic and efficient workflow into the ... procedures. On the clinical, technical, functional ... out how AXIOM Artis TA delivers ...
Spring Type with lock. Titanium....
Medicine Products: