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01 Dec 2019
Macrolide antibiotics are derived from the Streptomycesspecies. These contain either 14-membered (erythromycin [ERM],clarithromycin [CAM], roxithromycin [RXM]), 15-membered(azithromycin [AZM]) or 16-membered (spiramycin, josamycin,midecamycin) macrocyclic lactone rings. They inhibit proteinsynthesis by reversibly binding to the 23S ribosomal RNA (rRNA)in the 50s subunit of the bacterial ribosome. Traditionally,macrolides are used as first-line agents in respiratory, skin,soft tissue, and urogenital infections, and they are also activeagainst gram-positive cocci and atypical pathogens.
29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
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Nonsmall cell lung cancer (NSCLC) patients harbouring sensitive EGFR mutations may fare well with the third-generation tyrosine kinase inhibitor osimertinib as an upfront therapy, with the results of a network meta-analysis showing that the drug tops other currently available options in terms of progression-free survival and tolerability.
01 Dec 2019
Pneumonia is a common infection– affecting around 3,200 people inSingapore in 2016 – making it the thirdmost common cause of hospitalisation inthe country. Its common complications,especially with delayed or inappropriatetreatment, include bacteraemia andseptic shock, lung abscesses, pleuraleffusions, empyema, pleurisy, respiratoryfailure and renal failure.

Original New Drug Application Approvals by US FDA (01 - 15 May 2018)

16 May 2018

New drug applications approved by US FDA as of 01 - 15 May which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

PLENVU

  • Active Ingredient(s): polyethylene glycol (PEG) 3350; sodium ascorbate; sodium sulfate; ascorbic acid; sodium chloride; potassium chloride
  • Strength: 140G; 48.11G; 9G; 7.54G; 5.2G; 2.2G
  • Dosage Form: Solution
  • Company: Salix Pharms Inc.
  • Approval Date: 04 May 2018
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for cleansing of the colon in preparation for colonoscopy in adults
  • Approved Label04/05/2018 (PDF)
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
  • Active Ingredient(s): Lamivudine; Tenofovir disoproxil fumarate
  • Strength: 300MG; 300MG
  • Dosage Form: Tablet
  • Company: Aurobindo Pharma Ltd.
  • Approval Date: 15 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg
  • Approved Label: 15/05/2018 (PDF)
RETACRIT
  • Active Ingredient(s): Epoetin alfa-epbx
  • Strength: 2,000 UNITS/ML;  3,000 UNITS/ML;  4,000 UNITS/ML;  10,000 UNITS/ML;  40,000 UNITS/ML
  • Dosage Form: Injectable
  • Company: Hospira Inc.
  • Approval Date: 15 May 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Treatment of anemia due to
      • Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis
      • Zidovudine in patients with HIV-infection
      • The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy
    • Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery
  • Approved Label: 15/05/2018 (PDF)
BENDAMUSTINE HYDROCHLORIDE
  • Active Ingredient(s): Bendamustine hydrochloride
  • Strength: 100 MG
  • Dosage Form: Injectable
  • Company: Eagle Pharms
  • Approval Date: 15 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer    
  • Indication(s): Indicated for treatment of patients with:
    • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established
    • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen
  • Approved Label28/05/2018 (PDF)
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Most Read Articles
01 Dec 2019
Macrolide antibiotics are derived from the Streptomycesspecies. These contain either 14-membered (erythromycin [ERM],clarithromycin [CAM], roxithromycin [RXM]), 15-membered(azithromycin [AZM]) or 16-membered (spiramycin, josamycin,midecamycin) macrocyclic lactone rings. They inhibit proteinsynthesis by reversibly binding to the 23S ribosomal RNA (rRNA)in the 50s subunit of the bacterial ribosome. Traditionally,macrolides are used as first-line agents in respiratory, skin,soft tissue, and urogenital infections, and they are also activeagainst gram-positive cocci and atypical pathogens.
29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
Jairia Dela Cruz, 3 days ago
Nonsmall cell lung cancer (NSCLC) patients harbouring sensitive EGFR mutations may fare well with the third-generation tyrosine kinase inhibitor osimertinib as an upfront therapy, with the results of a network meta-analysis showing that the drug tops other currently available options in terms of progression-free survival and tolerability.
01 Dec 2019
Pneumonia is a common infection– affecting around 3,200 people inSingapore in 2016 – making it the thirdmost common cause of hospitalisation inthe country. Its common complications,especially with delayed or inappropriatetreatment, include bacteraemia andseptic shock, lung abscesses, pleuraleffusions, empyema, pleurisy, respiratoryfailure and renal failure.