Navigation Links
FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
Date:1/24/2008

evaluate its MOXATAG product candidate for pediatric patients less than 12 years of age with pharyngitis and/or tonsillitis as part of a post-marketing commitment. The Company has agreed to submit a completed study report and data set for MOXATAG in pediatric patients less than 12 years old within the next five years as part of this commitment.

"Compared to four times daily penicillin, once-daily MOXATAG has shown comparable efficacy and tolerability in eradicating Group A streptococcal infections of the pharynx. However, the once-daily dosing of MOXATAG is a major advantage," said lead study investigator Stan L. Block, M.D., professor of clinical pediatrics at the Universities of Louisville and Kentucky Medical Schools. "For the first time, physicians in the U.S. have the option of an FDA-approved once-daily amoxicillin therapy to treat their adolescent and adult patients with pharyngitis/tonsillitis. This should ensure better first- line therapy compliance with a penicillin class of antibiotic."

Clinical Trial Results Summary

The approval of MOXATAG was based on MiddleBrook's Phase 3 clinical study of more than 600 adults and pediatric patients 12 years and older in a double- blind, double-dummy, randomized, parallel-group, 50-center non-inferiority trial. The Company compared its MOXATAG tablet for the treatment of pharyngitis/tonsillitis due to Streptococcus pyogenes (Group A streptococcus) delivered in a once-daily, 775 milligram tablet for a period of 10 days to 250 milligrams of penicillin dosed four times daily, for a total of one gram per day, for 10 days.

Bacteriological eradication at the post-therapy test-of-cure visit in the per-protocol population was 85.0 percent (198/233) of patients with MOXATAG and 83.4 percent (191/229) with penicillin. These results demonstrate statistical non-inferiority (95 percent confidence interval of -5.1, 8.2). The per-protocol patient population included patients with confirmed Group A strepto
'/>"/>

SOURCE MiddleBrook Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
2. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
3. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
4. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
5. Childrens Hospital Cancer Study Finds Adolescents and Young Adults Dont Get Same Access to Cutting-Edge Treatment as Younger Patients
6. Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
7. Surgeons Find That Laparoscopic Banding Procedure Helps Overweight Adolescents Lose Weight and Improve Health
8. New Data Show Unacceptably Low Adult Immunization Rates and That Adults Unaware of Infectious Disease Threat
9. Photo: Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes
10. Post-Hoc Data Show Daily Activity Participation, Independence and Sleep Quality Improved in Adults with Moderate to Severe Rheumatoid Arthritis After Treatment with ORENCIA(R) (Abatacept)
11. Five-Year Data Demonstrate Long-Term Efficacy and Safety with ORENCIA(R) (abatacept) in Adults with Rheumatoid Arthritis Who had an Inadequate Response to Methotrexate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/15/2014)... /PRNewswire-iReach/ -- Asthma is a chronic inflammatory lung ... most commonly starts in childhood. It is a ... airways, leading to airflow limitation and airway hyper-responsiveness ... endogenous and exogenous irritants. Exposure to irritants instigates ... the airways, tightening of the respiratory muscles, and ...
(Date:9/15/2014)... , Sept. 15, 2014  Valeant Pharmaceuticals International, Inc. ... its wholly owned subsidiary, Valeant Pharmaceuticals International, will redeem ... of its 6.75% Senior Notes due 2017, CUSIP Nos. ... 2014 and has mailed an irrevocable notice of redemption ... a copy of the irrevocable notice of redemption with ...
(Date:9/15/2014)... 15, 2014  Decision Resources Group,s new ... finds that online information and other value-added ... differentiate their offering and support physicians. Physicians ... decisions rely on websites, mobile apps and ... these physicians are looking to manufacturers to ...
Breaking Medicine Technology:Asthma Market to Reach 161.02 million Cases in 10MM by 2023 2Asthma Market to Reach 161.02 million Cases in 10MM by 2023 3Asthma Market to Reach 161.02 million Cases in 10MM by 2023 4Asthma Market to Reach 161.02 million Cases in 10MM by 2023 5Valeant Announces Redemption of All of the Outstanding $500.0 Million Aggregate Principal Amount of its 6.75% Senior Notes due 2017 2Physician device decision-makers show strong demand for device manufacturer digital content and support 2Physician device decision-makers show strong demand for device manufacturer digital content and support 3
... Oct. 28 Thoratec Corporation (Nasdaq: THOR ... therapies to save, support and restore failing hearts, said ... 2010 increased 40 percent versus the third quarter of ... the third quarter and first nine months of 2010 ...
... Oct. 28 As part of its continued commitment ... CTIA–The Wireless Association® today announced that it is hosting ... World Forum for Medicine and International Trade Fair and ... mobile products, applications and network management solutions focused on ...
Cached Medicine Technology:Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 2Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 3Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 4Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 5Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 6Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 7Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 8Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 9Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 10Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 11Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 12Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 13Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 14Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 15Thoratec Reports 40 Percent Increase in Third Quarter Revenues From Continuing Operations 16CTIA-The Wireless Association® to Host First Wireless Health Pavilion at MEDICA 2010 World Forum for Medicine 2CTIA-The Wireless Association® to Host First Wireless Health Pavilion at MEDICA 2010 World Forum for Medicine 3
(Date:9/16/2014)... patients who received hypofractionated (HPFX) radiation therapy (RT) ... as bladder and bowel function were at similar ... presented today at the American Society for Radiation ... that parallel quality of life outcomes occurred between ... HPFX RT. , The phase I/II trial enrolled ...
(Date:9/16/2014)... (PET) tracer is effective in diagnosing concussion-related brain disease ... case study conducted at the Icahn School of Medicine ... in New Haven, and published September 16 in the ... results suggest that an experimental radiolabeled compound called [18 ... called tau that accumulates in the brain with repetitive ...
(Date:9/16/2014)... any other workplace incident, a statistic that transport safety ... being hosted by QUT,s Centre for Accident Research & ... in Transport Conference (OSIT) to be held on the ... experts from all facets of transport safety including roads, ... safety. , CARRS-Q research fellow Darren Wishart said the ...
(Date:9/16/2014)... soon better predict a man,s risk of getting prostate ... the largest-ever analysis of the cancer,s genetic biomarkers, reported ... of Health and Biomedical Innovation,s Dr Jyotsna Batra and ... in the large consortia of research hubs around the ... genetic markers in 80,000 men. , "It,s the largest ...
(Date:9/16/2014)... September 16, 2014 Non-small cell lung cancer (NSCLC) ... smokers at the time of diagnosis have a ... (SPLC) compared to those who are current smokers, ... a higher risk of SPLC, according to research ... Oncology,s (ASTRO,s) 56th Annual Meeting. , The analysis ...
Breaking Medicine News(10 mins):Health News:Prostate cancer patients who receive hypofractionated RT report consistent QoL 2Health News:Prostate cancer patients who receive hypofractionated RT report consistent QoL 3Health News:Neuroimaging technique identifies concussion-related brain disease in living brain 2Health News:Neuroimaging technique identifies concussion-related brain disease in living brain 3Health News:CARRS-Q Host International Transport Safety Conference 2Health News:New gene research helps pinpoint prostate cancer risk 2Health News:NSCLC patients who never smoked or who quit smoking have lower risk of developing secondary cancers 2Health News:NSCLC patients who never smoked or who quit smoking have lower risk of developing secondary cancers 3
... heart attack and stroke, U.S. officials say , , ... Prilosec with the popular blood thinner Plavix (clopidogrel) can ... at risk for heart attack or stroke, U.S. health ... recently submitted studies by the manufacturer of clopidogrel [Sanofi-Aventis ...
... Seattle Sutton,s Healthy Eating (SSHE) and the ... MCHC affiliated members with meal discounts for SSHE. , ... than 140 hospitals and health care organizations dedicated to improving ... care and in assisting its members in improving the delivery ...
... Mo. Until recently, scientists believed that, following a ... any lost function. After that, patients would be forced ... their remaining abilities. Although this belief has been refuted, ... the current health system is still not giving patients ...
... 17 As we approach Thanksgiving, "Black Friday" and the ... community to please remember the children and families whose lives ... recovery and survival. Among these diseases are leukemia and ... disease, hemophilia and other diseases. , Please take a few ...
... VEGAS, Nov. 17 Ultimat Vodka has recently announced plans ... eliminating world hunger, to help raise awareness and funds for ... "I,m Tired of...," (ITo) Ultimat has created unique wrist ... message "I,m Tired of Hunger." For each bracelet produced, Ultimat ...
... surgery, gunshot victim continues to show improvement , TUESDAY, ... the first facial transplant in the United States can ... her nose, according to a report from her surgeons. ... from the transplanted tissue have integrated with existing tissue, ...
Cached Medicine News:Health News:Heartburn Drugs Can Thwart Popular Blood Thinner 2Health News:Seattle Sutton's Healthy Eating Partners With Metropolitan Chicago Healthcare Council to Provide Discounts for Hospital Patients and Employees 2Health News:Seattle Sutton's Healthy Eating Partners With Metropolitan Chicago Healthcare Council to Provide Discounts for Hospital Patients and Employees 3Health News:Pushing the brain to find new pathways 2Health News:These Patients Need Your Help This Thanksgiving 2Health News:These Patients Need Your Help This Thanksgiving 3Health News:Ultimat Vodka Joins Fight Against Hunger 2Health News:Face Transplant Patient Can Smell, Taste, Breathe Normally 2Health News:Face Transplant Patient Can Smell, Taste, Breathe Normally 3
... 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 ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: