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 - 31 October 2019)

31 Oct 2019
New drug application approved by US FDA as of 16 - 31 October 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.

AMZEEQ
  • Active Ingredient(s): Minocycline
  • Strength: 4%
  • Dosage Form(s) / Route(s):Aerosol, foam; topical
  • Company: Foamix Pharma, Inc.
  • Approval Date: 18 October 2019
  • Submission Classification: Not available
  • Indication(s): Indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
  • Approved Label18 October 2019 (PDF)

TRIKAFTA
  • Active Ingredient(s): Elexacaftor, tezacaftor, ivacaftor; ivacaftor
  • Strength: 100 mg, 75 mg, 50 mg; 150 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Vertex Pharms, Inc.
  • Approval Date: 21 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene. If the patients's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation.
  • Approved Label21 October 2019 (PDF)

BIORPHEN
  • Active Ingredient(s): Phenylephrine hydrochloride
  • Strength: 0.1 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Sintetica SA
  • Approval Date: 21 October 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
  • Approved Label21 October 2019 (PDF)

VUMERITY
  • Active Ingredient(s): Diroximel fumarate
  • Strength: 231 mg
  • Dosage Form(s) / Route(s): Capsule, delayed release; oral
  • Company: Alkermes
  • Approval Date: 29 October 2019
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 
  • Approved Label29 October 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.