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.
Roshini Claire Anthony, 6 days ago

The presence of pulmonary arterial hypertension (PAH) in individuals with systemic sclerosis is associated with an increased mortality risk, a study from Singapore showed.

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.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.

Original New Drug Application Approvals by US FDA (01 - 15 January 2020)

15 Jan 2020
New drug applications approved by US FDA as of 01 - 15 January 2020 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.

AYVAKIT
  • Active Ingredient(s): Avapritinib
  • Strength: 100 mg; 200 mg; 300 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Blueprint Medicines Corp
  • Approval Date: 09 January 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
  • Approved Label09 January 2020 (PDF)

VALTOCO
  • Active Ingredient(s): Diazepam
  • Strength: 5 mg; 7.5 mg; 10 mg
  • Dosage Form(s) / Route(s): Spray; nasal
  • Company: Neurelis, Inc.
  • Approval Date: 10 January 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older.
  • Approved Label10 January 2020 (PDF)

NUMBRINO
  • Active Ingredient(s): Cocaine hydrochloride
  • Strength: 40 mg/mL
  • Dosage Form(s) / Route(s): Solution; nasal
  • Company: Cody Laboratories, Inc.
  • Approval Date: 10 January 2020
  • Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
  • Indication(s): Indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.
  • Approved Label10 January 2020 (PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Doctor - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
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.
Roshini Claire Anthony, 6 days ago

The presence of pulmonary arterial hypertension (PAH) in individuals with systemic sclerosis is associated with an increased mortality risk, a study from Singapore showed.

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.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.