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:7/2/2015)... July 2, 2015 Releases of ... Aedes aegypti , , reduced the dengue ... Brazil by 95%, well below the modelled ... http://photos.prnewswire.com/prnh/20150630/227348LOGO) , The journal PLOS Neglected Tropical ... Oxitec,s genetically engineered mosquitoes. The results showed that in ...
(Date:7/2/2015)... 2015 According to a new market ... Stimulation, Spinal Cord Stimulation, Transcranial Magnetic Stimulation), Application (Depression, Parkinson,s, ... 2020", published by MarketsandMarkets, the global Neuromodulation Market is estimated ... $6.20 Billion by 2020, at a CAGR of 11.2% during ... 4 market data T ables and ...
(Date:7/2/2015)... 25, 2015 Research and Markets( http://www.researchandmarkets.com/research/nlfg34/cancer ... by Technology, Imaging and by Application - Forecast to 2020" ... is expected to reach $13.1 Billion in 2020 from an estimated ... The market is dominated by North America ... , and Rest of the World (RoW). The cancer diagnostics ...
Breaking Medicine Technology:Oxitec Mosquito Works to Control Aedes aegypti in Dengue Hotspot 2Oxitec Mosquito Works to Control Aedes aegypti in Dengue Hotspot 3Neuromodulation Market Worth $6.20 Billion by 2020 2Neuromodulation Market Worth $6.20 Billion by 2020 3Neuromodulation Market Worth $6.20 Billion by 2020 4Global Cancer Diagnostics Market Report 2015 - Technology, Imaging and by Applications Forecasts to 2020 for the $13 Billion Industry 2
... Oramed,Pharmaceuticals, Inc. (OTCBB: ORMP.OB) ( http://www.oramed.com ), ... that its abstract, entitled "Open,Label Study to ... of Five Oral Insulin Formulations in Healthy,Subjects," ... upcoming 44th Annual,Meeting of the European Association ...
... Industry Leader with Strong Clinical Research Relationships and ... Organizations to Lead Commercialization, SANTA CLARA, Calif., ... a cardiac diagnostic and services company, today,announced that ... president. Mr.,Renz will oversee the Company,s commercialization effort, ...
Cached Medicine Technology:Oramed Pharmaceuticals Chosen to Present Oral Insulin Trial Results at EASD Conference (September 7-11, Rome) 2Vincent W. Renz Joins NewCardio as President 2Vincent W. Renz Joins NewCardio as President 3Vincent W. Renz Joins NewCardio as President 4
(Date:7/2/2015)... ... July 02, 2015 , ... sweetFrog Enterprises, LLC. is pleased to announce ... first sweetFrog store located in Mississippi. The premium frozen yogurt chain was listed as ... store, located at 104 Railroad Avenue, New Albany, MS 38652, will have a grand ...
(Date:7/2/2015)... ... July 02, 2015 , ... Following the recent report by JAMA ... Americans outnumber merely overweight Americans, Samir Becic emphatically declared a war on obesity in ... right now," Becic said. "We must understand the magnitude of this discovery. For that ...
(Date:7/2/2015)... ... July 02, 2015 , ... Many Fourth of July ... That’s why Amica Insurance is sharing some tips to promote the proper ... 230 people go to the emergency room daily with fireworks-related injuries in the month ...
(Date:7/2/2015)... ... ... LIFX ” was featured on NewsWatch as part of its monthly Tech Report, which ... expert and special reporter for NewsWatch, conducted the review and shared with viewers how ... According to the U.S. Department of Energy, it’s very important to use energy-efficient light ...
(Date:7/2/2015)... ... 02, 2015 , ... Global leader and compression innovator, SIGVARIS North ... , For style that’s quick on its feet, men will love this fun ... for men everywhere because a simple change in socks can dramatically help improve overall ...
Breaking Medicine News(10 mins):Health News:sweetfrog Opens First Location in Mississippi 2Health News:Samir Becic's Health Fitness Revolution Declares War Against Obesity in America 2Health News:Samir Becic's Health Fitness Revolution Declares War Against Obesity in America 3Health News:Samir Becic's Health Fitness Revolution Declares War Against Obesity in America 4Health News:6 Fireworks Safety Tips from Amica Insurance 2Health News:The Most Versatile Smart Light Bulbs were featured on NewsWatch Television 2Health News:SIGVARIS Kicks Up Its Style for Men with the Launch of MIDTOWN MICROFIBER in a Dark Navy Stripe Pattern 2Health News:SIGVARIS Kicks Up Its Style for Men with the Launch of MIDTOWN MICROFIBER in a Dark Navy Stripe Pattern 3
... Randy Dotinga HealthDay Reporter , TUESDAY, Dec. 6 (HealthDay ... nice house to a handy jet at your disposal, but the ... take years off your life? Maybe not, new research suggests. ... seem to lose years off their lives due to the effects ...
... at the meeting, which is being held in Budapest, ... using echocardiography to document early warning signs of adverse ... echocardiography to evaluate the protective role of ACE inhibitors ... "These studies open the way for the early identification ...
... HealthDay Reporter , TUESDAY, Dec. 6 (HealthDay News) -- ... tired; it may also increase your risk of developing type 2 ... of women found that those who worked rotating night shifts were ... hours, and the longer that they worked a rotating shift schedule, ...
... are too poor to afford pacemakers. But a study has ... and implanting them in Indian patients "is very safe and ... is a co-author of the study, published online ahead of ... helped conduct the research before coming to Loyola while he ...
... Supercomputer simulations at the Department of Energy,s Oak Ridge ... key class of proteins involved in drug detoxification. ... affiliated with ORNL and the University of Tennessee, have ... in a class of enzymes called P450s. Certain types ...
... HealthDay Reporter , TUESDAY, Dec. 6 (HealthDay News) ... hormone therapy do not appear to be at increased risk ... review of evidence. Hormone therapy called "androgen deprivation ... studies found that the therapy might increase the risk of ...
Cached Medicine News:Health News:Most U.S. Presidents Live Longer Than Their Peers 2Health News:EUROECHO 2011: Importance of echocardiography to evaluate cardio toxicity in cancer patients 2Health News:EUROECHO 2011: Importance of echocardiography to evaluate cardio toxicity in cancer patients 3Health News:EUROECHO 2011: Importance of echocardiography to evaluate cardio toxicity in cancer patients 4Health News:Rotating Shift Work May Boost Women's Diabetes Risk 2Health News:Rotating Shift Work May Boost Women's Diabetes Risk 3Health News:Reusing pacemakers from deceased patients is safe and effective, study finds 2Health News:Supercomputer reveals new details behind drug-processing protein model 2Health News:Hormone Drugs Might Not Raise Heart-Related Deaths in Prostate Patients 2Health News:Hormone Drugs Might Not Raise Heart-Related Deaths in Prostate Patients 3
The ultra micro tip for the new Eppendorf 2000/2100 series ultra micro pipettors provides accurate drawing and dispensing everytime....
... available as both regular and filter tips. ... for more efficient sterilization and are delivered ... date of irradiation. Sterilized Diamond Tips are ... SterilPack Diamond Tips are wrapped in medical ...
This ultra micro tip for the Eppendorf and Nichiryo/BenchMate 0.5-10 L pipettors is perfect for working with low volume....
1000 L, Bulk Recommended for 500 and 1000 L pipettes....
Medicine Products: