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:10/1/2014)... 1, 2014 Sophia Genetics, ... domaine de l,analyse des données issues du SNG ... de diagnostic in vitro (IVD) du gène CFTR ... la mucoviscidose dans un seul essai SGN. La ... les types de variantes par l,intermédiaire d,un seul ...
(Date:9/30/2014)... -- Hologic, Inc. (NASDAQ: HOLX ), today announced ... Executive Officer, will preside over the NASDAQ Stock Market ... of Breast Cancer Awareness Month. In his remarks, Mr. ... important benefits of Hologic,s 3D Mammography technology, the only ... to traditional mammography. This is the ninth ...
(Date:9/30/2014)... , Sept. 30, 2014 Arbor Pharmaceuticals, ... Summary Global Markets Direct,s, ,Arbor Pharmaceuticals, LLC. ... overview of the Arbor Pharmaceuticals, LLC.,s pharmaceutical research ... information on the current therapeutic developmental pipeline of ... various stages, therapeutics assessment by drug target, mechanism ...
Breaking Medicine Technology:Sophia Genetics lance une analyse complète du gène CFTR dans un essai clinique SGN 2Sophia Genetics lance une analyse complète du gène CFTR dans un essai clinique SGN 3Hologic to Kick Off National Breast Cancer Awareness Month at the October 1 NASDAQ Stock Market Opening Bell Ceremony 2Hologic to Kick Off National Breast Cancer Awareness Month at the October 1 NASDAQ Stock Market Opening Bell Ceremony 3Arbor Pharmaceuticals, LLC. - Product Pipeline Review - 2014 2Arbor Pharmaceuticals, LLC. - Product Pipeline Review - 2014 3
... 2011 Volcano Corporation (NASDAQ: VOLC ), ... and therapy guidance tools designed to enhance the treatment ... it will be participating in the Tenth Annual JMP ... The presentation by John Dahldorf, chief financial officer, will ...
... May 2, 2011 SeraCare Life Sciences announced today ... of the National Institutes of Health has awarded a ... expired on April 30, 2011. Under this contract, SeraCare, ... proper collection, processing and storage for biorepository collections. SeraCare ...
Cached Medicine Technology:SeraCare Life Sciences Announces Renewal of National Institutes of Health Contract to Support Research 2SeraCare Life Sciences Announces Renewal of National Institutes of Health Contract to Support Research 3
(Date:10/1/2014)... Angeles, CA (PRWEB) October 01, 2014 ... power score of 3.1 out of 5, which ... users include food and beverage manufacturers, food service ... As a result of these users' diversity, demand ... As such, rising industrial production, consumer spending and ...
(Date:10/1/2014)... (PRWEB) October 01, 2014 To help raise ... center , Cutler Integrative Medicine, is detailing several tips for ... , According to Dr. Cutler, women should start each ... time for yourself that will help ‘center’ yourself for the ... stress,” he says. , Other health and fitness tips ...
(Date:10/1/2014)... CO (PRWEB) October 01, 2014 Nearly ... after a Pueblo County District Court jury awarded him ... cancer at 61 years old. Casper had been ... , According to the Court Documents (District ... treated for BPH, a benign non-cancerous condition of his ...
(Date:9/30/2014)... be proactive about potential disease outbreaks like Ebola and ... an Editorial in the October issue of Australian ... Cheng from Monash University and Heath Kelly from the ... crises. , "Australia would do well to heed the ... co-ordinating a consistent and outward looking response," the authors ...
(Date:9/30/2014)... (HealthDay News) -- There,s no genetic evidence that high ... a new study says. Some previous research had ... people against type 2 diabetes, raising the possibility of ... sugar disease. In this study, British researchers investigated ... focusing on genes that control blood levels of vitamin ...
Breaking Medicine News(10 mins):Health News:Industrial Freezers Procurement Category Market Research Report Now Available from IBISWorld 2Health News:Industrial Freezers Procurement Category Market Research Report Now Available from IBISWorld 3Health News:Industrial Freezers Procurement Category Market Research Report Now Available from IBISWorld 4Health News:In Recognition of National Women’s Health and Fitness Day, Cutler Integrative Medicine Details Tips for Living a Healthier and Happier Life 2Health News:Law Offices of D.R. Jones Client Wins 4.7 Million Dollar Verdict, Insurance Company Files Motion for a New Trial 2Health News:Law Offices of D.R. Jones Client Wins 4.7 Million Dollar Verdict, Insurance Company Files Motion for a New Trial 3Health News:Gene Study Finds No Proof Vitamin D Guards Against Type 2 Diabetes 2
... -- Racism is similar to trauma in how it ... United States, a new analysis finds. An examination ... black adults concluded that there are common responses to ... is expressed as physical pain), interpersonal sensitivity and anxiety. ...
... Nov. 24 (HealthDay News) -- Black Friday, the kickoff to ... as it is about getting good deals, according to a ... Friday adventure phenomenon, the more fun you,re likely to add ... Wake Forest University, said in a university news release. ...
... -- A 36-year-old husband and father of two children with ... world,s first artificial trachea made with stem cells. ... described the transplant surgery, which was performed in June ... the transplant, the authors of the report explained, the man ...
... By Jenifer Goodwin HealthDay Reporter , WEDNESDAY, ... Americans are hospitalized for adverse drug reactions yearly, and ... a new study finds. The four types of ... -- account for two-thirds of those drug-related emergency hospitalizations. ...
... that treats Type-2 diabetes has been shown to prevent ... the growth of breast cancer cells, according to a ... The research, led by pediatrics professor James Trosko ... biological evidence for previously reported epidemiological surveys that long-term ...
... , WEDNESDAY, Nov. 23 (HealthDay News) -- Preschoolers who ... are often prescribed inhaled steroid medication, and new research ... as-needed basis instead of every day. Respiratory ... and the treatment for some of these kids -- ...
Cached Medicine News:Health News:1st Artificial Windpipe Made With Stem Cells Seems Successful 2Health News:Four Common Meds Send Thousands of Seniors to Hospital: CDC 2Health News:Four Common Meds Send Thousands of Seniors to Hospital: CDC 3Health News:Diabetes drug shows promise in reducing risk of cancer 2Health News:Intermittent Steroid Use Called OK for Wheezing Preschoolers 2Health News:Intermittent Steroid Use Called OK for Wheezing Preschoolers 3
... The National Laboratory Training Network (NLTN) ... Association of Public Health Laboratories (APHL) and ... (CDC). NLTN provides cost-effective training in a ... resources, including a FREE Lending Library. Log ...
... The AAFP-PT Laboratory Proficiency Testing and ... programs are designed to assist POLs, clinics ... are designed to assure accuracy of patient ... regulatory requirements. Participation provides the opportunity to ...
An indirect immunofluorescence (IFA) antibody test for the detection and semiquantitation of anti-glomerular basement membrane (GBM) antibodies in human serum. Slide Detail: 6-well Monkey Kidney Subs...
An enzyme linked immunosorbant assay (ELISA) for the detection and quantitation of Rheumatoid Factor (RF) of IgM isotype in human serum....
Medicine Products: