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

Amoxicillin PULSYS to be Marketed as MOXATAG(TM) - First Once-Daily

Amoxicillin Product Approved in U.S.

GERMANTOWN, Md., Jan. 24 /PRNewswire-FirstCall/ -- MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK), a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced that it has received approval of its New Drug Application (NDA) from the U.S. Food and Drug Administration (FDA), for its once-daily MOXATAG(TM) Tablets 775 mg (amoxicillin extended-release tablets) for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).

The FDA approval was based on results from a Phase 3 clinical study conducted with more than 600 patients that found once-daily MOXATAG for 10 days was effective in eradicating bacteria responsible for strep throat and demonstrated statistical non-inferiority to a four times daily dose of penicillin for 10 days. MOXATAG was very well tolerated in the clinical trial.

"We are extremely gratified to have received FDA approval of our MOXATAG NDA," stated Edward Rudnic, Ph.D., president and CEO of MiddleBrook. "As the first and only once-daily amoxicillin therapy approved for marketing in the United States, we believe MOXATAG represents a major advance for patients and doctors seeking safe, effective, and convenient treatment options for strep throat. We now look forward to continuing our ongoing strategic evaluation process from a position of greater strength with this approval in hand."

In accordance with the requirements of the Pediatric Research Equity Act, MiddleBrook has agreed with the FDA to further
'/>"/>

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:6/30/2015)... CARLSBAD, Calif. , June 30, 2015 /PRNewswire/ ... Inc. company (Nasdaq: NTK ) and a ... smart control markets, today announced it acquired mobile ... assets from privately held Numera, Inc. ... Numera creates best-in-class, easily implemented, mobile PERS products ...
(Date:6/30/2015)... June 30, 2015   Millar, Inc. , a ... announced the 2016 retirement of Craig Thummel , ... 12 years of service to the Company. The Company ... senior members of the Executive Management team as his ... Daugherty , currently Director of Sales and Marketing, as ...
(Date:6/30/2015)... Research and Markets( ... "Global Array Instruments Market 2015-2019" report ... instruments market to grow at a CAGR of ... global array instruments market can be divided into ... including tissue microarrays and cell microarrays. This report ...
Breaking Medicine Technology:Nortek Security & Control Acquires Health and Wellness Technology Business from Numera 2Nortek Security & Control Acquires Health and Wellness Technology Business from Numera 3Nortek Security & Control Acquires Health and Wellness Technology Business from Numera 4Millar, Inc. Announces Leadership Changes 2Millar, Inc. Announces Leadership Changes 3Global Array Instruments Market 2015-2019 - Advances in Personalized Medicines with Affymetrix, Agilent Technologies & Illumina Dominating 2
... Princeton HealthCare System (PHCS) ( www.princetonhcs.org ) will conduct its ... hosts a discussion about women,s pelvic floor disorders and treatment ... p.m. and can be joined by going to the PHCS ... has enormous potential for sharing information about health issues," said ...
... BEVERLY HILLS, Calif., Sept. 20 Waismann Method ... the first-ever National Take-Back Initiative, organized by the U.S. ... to encourage the public to surrender expired, unwanted or ... heels of recent reports that prescription drug abuse and ...
Cached Medicine Technology:First Live Web Chat by New Jersey's Princeton HealthCare System Focuses on Women's Health 2Waismann Method Supports National Take-Back Initiative 2Waismann Method Supports National Take-Back Initiative 3
(Date:6/30/2015)... (PRWEB) , ... June 30, 2015 , ... ... Good Neighbor Pharmacy’s premier event and tradeshow, taking place July 29 to August ... purchasing decision makers. , ThoughtSpot is a four-day event for independent ...
(Date:6/30/2015)... ... 2015 , ... The American Lung Association in California announced its new partnership ... Speakers and clean air advocates included San Diego County Supervisor Ron Roberts, Dr. Atul ... Daniel Sullivan, founder and president of Sullivan Solar Power. , For every solar ...
(Date:6/30/2015)... ... June 30, 2015 , ... ... Rehab”. The video focuses on the rehab center’s patients and their experiences at ... the best quality of services available. Each patient attests to the high rating, ...
(Date:6/30/2015)... ... ... According to a June 15th report from USC News, a ... can be used to “decrease children’s anxiety and negative responses during oral care.” The ... patient experience in a “typical dental environment” with one that provides “visual, auditory and ...
(Date:6/30/2015)... Beach, CA (PRWEB) , ... June 30, 2015 , ... ... Skilled Nursing”, which features multiple patient and family member testimonials. Medicare rated the care ... country. Broadway plans to use the video to give future patients a firsthand look ...
Breaking Medicine News(10 mins):Health News:Retail Management Solutions to Attend Amerisource's ThoughtSpot 2015 Conference and Trade Show 2Health News:Retail Management Solutions to Attend Amerisource's ThoughtSpot 2015 Conference and Trade Show 3Health News:Local Dignitaries Gather to Announce San Diego’s Clean Air Challenge 2Health News:Local Dignitaries Gather to Announce San Diego’s Clean Air Challenge 3Health News:Patients of University Post-Acute Rehab Support Five-Star Rating in New Video 2Health News:New Study Aims to Determine if Sensory Stimuli can Ease Dental Anxiety in Children, Notes Medical Center Dental Care 2Health News:New Study Aims to Determine if Sensory Stimuli can Ease Dental Anxiety in Children, Notes Medical Center Dental Care 3Health News:Broadway by the Sea Video Promotes Top Quality Service 2
... School is presenting a paper at the 109th Annual ... Otolaryngology being held September 25-28, 2005 on the impact ... involved 514 adult patients with inflammatory paranasal sinus disease ... paranasal sinus disease is used to encompass CRS, CRS ...
... in the plant kingdom among pulses. Besides providing the body ... to have numerous other health benefits//. It is nicknamed as ... of diabetes, and improve overall health. ,Sometime back ... the Post menopausal period but now men have a reason ...
... the introduction of computers to the health care delivery ... potential in improving diagnosis and treatment modalities. // , ... detect more breast cancers, but also helps detect smaller ... included 27,274 screening mammograms done over a three year ...
... excess weight that one has to carry like excess baggage everywhere. ... that adopted earlier that is the basic principle which is to ... big problem these days., ,Calorie counting - and calorie ... ,With so many dietary plans jostling for attention - low ...
... It is estimated that India has an estimated 5.1 million ... Kalam on Friday in Shillong (capital of the northeastern state ... would be available in India in three to four years., ... worst affected areas in India and the AIDS virus has ...
... small increase in the malfunction of the kidneys can ... patients suffering from acute kidney injury (AKI). Researchers from ... results in the latest issue of the Journal of ... analyzed data on 9,210 hospitalized patients who underwent serum ...
Cached Medicine News:Health News:Age Can Changes Symptoms Of Sinusitis 2
Telescopic Diamond-Dissectors for delicate sharp tissue preparation. Total/working lengths 220/240 mm with protective sleeve....
Epstein Curettes 3.0 mm, length 8" (203 mm)....
Cobb Spinal Curettes, tip size 13.00 mm, length 11" (279 mm)....
Karlin XL Magnum Ring Curettes, extra long (XL) curettes, black handles, lightweight. Length 13 1/4" (33.7 cm), handle length 8 1/2" (21 cm), handle diameter 1 1/4" (32 cm)....
Medicine Products: