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1.  Newly Approved Drug Therapies (977) Moxatag (amoxicillin), MiddleBrooke Pharmaceuticals,
...adults and pediatrics General Information Moxatag contains amoxicillin, a semi-synthetic antimicrobial belonging to the penicillin class of antimicrobials with activity against gram-positive and gram-negative bacteria. Moxatag is an ...
...and/or pharyngitis secondary to S. pyogenes. The subjects received Moxatag 775 mg QD or penicillin VK 250 mg QID, both for 10 days. Moxatag was determined to be non-inferior ...
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2.  CenterWatch: New Medical Therapies in Disease Category (321), Strep Throat
...data did not meet their primary efficacy endpoint, failing to achieve statistical non-inferiority to penicillin in bacterial eradication at post-therapy test-of-cure visit (65.3% vs. 68.0% ...
...of oral amoxicillin PULSYS (475 mg or 775mg once daily) or an oral suspension of penicillin (10 mg/kg 4 times daily) for 10 days. Pfizer issued positive results of a ...
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3.  CenterWatch: New Medical Therapies in Disease Category (119), Pharyngitis
...achieving bacterial eradication at the end of treatment, compared to 88.5% of subjects receiving penicillin. Secondary non-inferiority endpoints were also missed, including clinical cure at the test-of-cure ...
...who received either 775 mg Amoxycillin PULSYS once-daily for seven days or 250 mg penicillin VK four times daily for ten day. The companies anticipate that these results will delay ...
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4.  Newly Approved Drug Therapies (967) Doribax (doripenem), Johnson & Johnson,
...and urinary tract infections General Information Doribax is a synthetic, parenteral carbapenem antibiotic. It targets penicillin-binding proteins (PBPs) to inhibit the biosynthesis of the bacterial cell wall. Doribax is specifically ...
...Doripenem exerts its bactericidal activity by inhibiting bacterial cell wall biosynthesis. Doripenem inactivates multiple essential penicillin-binding proteins (PBPs) resulting in inhibition of cell wall synthesis with subsequent cell death. In ...
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5.  Study Posting (557) Trial #126276, Chronic Bronchitis, Clearwater, FL
...for a Clincal Research Study. Requirements: • Be at least 35 years old • Not allergic to penicillins or macrolides • History of smoking • Able to swallow pills/capsules • Have not taken an antibiotic ...
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6.  Newly Approved Drug Therapies (597) Tequin, Bristol-Myers Squibb,
...resistance of gram-positive bacteria. Therefore, it can treat some infections that other antibiotics like penicillin cannot. There were estimated to be 125 million cases of such infections last year in ...
...action from other antibiotics, thereby making it useful for infections that will not respond to penicillin, cephalosporins, macrolides, aminoglycosides, or tetrocyclines. Its antibacterial properties stem from an inhibition of DNA gyrase ...
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7.  Study Posting (3659) Trial #91421, Chronic Bronchitis, Spartanburg, SC
...for a Clinical Research Study. Requirements: • Be at least 35 years old • Not allergic to penicillins or macrolides • History of smoking or airflow obstruction • Able to swallow pills/capsules • Have not ...
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8.  Newly Approved Drug Therapies (19) Cedax (ceftibuten), Schering-Plough,
...enzymes produced by bacteria that can render some commonly used antibiotics, such as amoxicillin or penicillin, ineffective. Side Effects Clinical trials revealed a very low incidence of gastrointestinal side effects, including ...
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9.  Newly Approved Drug Therapies (117) Zosyn (sterile piperacillin sodium/tazobactam sodium), Wyeth,
...an injectable antibiotic consisting of beta-lactamase inhibitor, tazobactam, in combination with an extended-spectrum penicillin, piperacillin. The piperacillin component offers the safety and efficacy of a broad-spectrum, beta-lactam ...
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10.  Newly Approved Drug Therapies (215) Zagam (sparfloxacin) tablets, Rhone Poulenc Rorer,
...common lower respiratory tract infections. In addition, Zagam is highly active in vitro against many penicillin-resistant strains of the Gram-positive pathogen, Streptococcus pneumoniae, as well as multi-drug resistant ...
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11.  Newly Approved Drug Therapies (544) Amoxil (amoxicillin), SmithKline Beecham,
...Amoxil is contraindicated in patients with a history of allergic reaction to any of the penicillins. Jobson Medical Information • Privacy | • Glossary Copyright © 1995-2010 Jobson Medical Information LLC. Designed by Piehead ...
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12.  Newly Approved Drug Therapies (1061) Tygacil (tigecycline), Wyeth,
...Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (betalactamase negative isolates), and Legionella pneumophila ...
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13.  Newly Approved Drug Therapies (60) Augmentin (amoxicillin/clavulanate), SmithKline Beecham,
...Augmentin should not be used in subjects with a history of allergic reactions to any penicillin or with a previous history of Augmentin-associated cholestatic jaundice/hepatic dysfunction. Side Effects The ...
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14.  CenterWatch: New Medical Therapies in Disease Category (179), HIV Infections
...775 mg Amoxicillin PULSYS tablet, once a day, for 10 days or 250 mg of penicillin, four times a day, for 10 days. The trial met the primary endpoint of statistical ...
...inferiority with 85% of the PULSYS group achieving bacterial eradication versus 83.4% of the penicillin group. Secondary endpoints met statistical non-inferiority as well in clinical cure rates at the ...
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15.  CenterWatch: New Medical Therapies in Disease Category (465), Bacterial Infections
...775 mg Amoxicillin PULSYS tablet, once a day, for 10 days or 250 mg of penicillin, four times a day, for 10 days. The trial met the primary endpoint of statistical ...
...inferiority with 85% of the PULSYS group achieving bacterial eradication versus 83.4% of the penicillin group. Secondary endpoints met statistical non-inferiority as well in clinical cure rates at the ...
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16.  CenterWatch: New Medical Therapies in Disease Category (295), Cold Sores (Herpes Labialis Infections)
...775 mg Amoxicillin PULSYS tablet, once a day, for 10 days or 250 mg of penicillin, four times a day, for 10 days. The trial met the primary endpoint of statistical ...
...inferiority with 85% of the PULSYS group achieving bacterial eradication versus 83.4% of the penicillin group. Secondary endpoints met statistical non-inferiority as well in clinical cure rates at the ...
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17.  Newly Approved Drug Therapies (626) Cefazolin and Dextrose USP, B Braun Medical,
...multiple drug therapies. Transient hepatitis and cholestatic jaundice are also uncommon side effects associated with penicillin and cephalosporins. Other rare side effects include genital and anal pruritis and rare instances of ...
...corn products • currently taking probenecid Serious or fatal hypersensitivy has been reported in patients on penicillin therapy. Anaphalactic reactions are more likely to occur in patients that have a known history ...
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18.  Newly Approved Drug Therapies (750) Invanz, Merck,
...beta) methyl-carbapenem related to a class of antibiotics known as beta-lactams, which includes penicillins and cephalosporins. Invanz works by blocking the formation of bacterial cell walls, thereby causing cell ...
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19.  Study Posting (1918) Trial #159915, Leukemia, Savannah, GA
...thioguanine or mercaptopurine administration • No concurrent intensity-modulated radiotherapy • No concurrent nonsteroidal anti-inflammatory drugs, penicillin, or acetylsalicyclic acid-containing medications for at least 3 days after high-dose methotrexate Patricia ...
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20.  CenterWatch Clinical Industry Provider Profile(2913), Almac Clinical Services, Audubon, PA
...Specialised Manufacturing/Packaging Services Almac Clinical Services have specialised dedicated facilities for the packaging of penicillins and cephalosporins, it is also licensed to package controlled scheduled II to IV drug products ...
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