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, 4 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.

Original New Drug Application Approvals by US FDA (16 - 28 February 2019)

07 Mar 2019
New drug applications approved by US FDA as of 16 - 28 February 2019 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.

LOTEMAX SM
  • Active Ingredient(s): Loteprednol etabonate
  • Strength: 0.38%
  • Dosage Form(s) / Route(s): Gel; Ophthalmic
  • Company: Bausch and Lomb Inc.
  • Approval Date: 22 Feb 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of postoperative inflammation and pain following ocular surgery.
  • Approved Label: 22 Feb 2019 (PDF)
ADHANSIA XR
  • Active Ingredient(s): Methylphenidate hydrochloride
  • Strength: 25 mg; 35 mg; 45 mg; 55 mg; 70 mg; 85 mg
  • Dosage Form(s) / Route(s): Capsule; Extended release
  • Company: Purdue Pharma L.P.
  • Approval Date: 27 Feb 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.
  • Approved Label: 27 Feb 2019 (PDF)
HERCEPTIN HYLECTA
  • Active Ingredient(s): Trastuzumab; Hyaluronidase-oysk
  • Strength: 600 mg; 10000 units
  • Dosage Form(s) / Route(s): Injectable; Subcutaneous
  • Company: Genentech Inc.
  • Approval Date: 28 Feb 2019
  • Submission Classification:
  • Indication(s): Indicated in adults for the treatment of HER2-overexpressing breast cancer.
  • Approved Label: 28 Feb 2019 (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, 4 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.